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Data / Medical devices / United States / Richard-Allan Scientific LLC

Richard-Allan Scientific LLC: FDA-registered device maker in Kalamazoo, MI, United States, 2 510(k) clearances

Richard-Allan Scientific LLC is registered with the FDA (registration 1831638) in Kalamazoo, MI, United States. It lists 59 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 27, 2006. 8 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Richard-Allan Scientific LLC
FDA registration number
1831638
Address
4481 Campus DR., Kalamazoo, MI, United States, 49008
Owner or operator
Epredia Holdings Ltd. (10062642)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
First device listed
February 25, 2020
Registered through
2026
Brand names listed
(HBVsAg) 0.1ml (Culture Sup.), (HBVsAg) 0.5ml (Culture Sup.), (HBVsAg) 12ml RTU, (HBVsAg) 1mL, (HBVsAg) 7ml RTU, (PSMA) [SP29] 1mL, (VEGF) 0.5mL, 1% Acetic Acid Solution and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, PeriodicKKS1Manufactureraccessdata.fda.gov
Agent, ClearingKEM1Contract manufacturer, Manufactureraccessdata.fda.gov
Alcian BlueIDA1Manufactureraccessdata.fda.gov
Aniline BlueKFD1Manufactureraccessdata.fda.gov
Basic FuchsinKKW1Manufactureraccessdata.fda.gov
Biebrich ScarletICN1Manufactureraccessdata.fda.gov
Carbol FuchsinICL1Manufactureraccessdata.fda.gov
Cassettes, TissueIDZ1Manufactureraccessdata.fda.gov
Congo RedICH1Manufactureraccessdata.fda.gov
Container, EmbeddingKER1Manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Manufactureraccessdata.fda.gov
Crystal Violet For HistologyICF1Manufactureraccessdata.fda.gov
CytocentrifugeIFB1Contract manufacturer, Manufactureraccessdata.fda.gov
Eosin YHYB1Complaint file establishment, Manufactureraccessdata.fda.gov
Fast GreenHYC1Manufactureraccessdata.fda.gov
Fixative, Acid ContainingLDW1Contract manufacturer, Manufactureraccessdata.fda.gov
Fixative, Alcohol ContainingLDZ1Contract manufacturer, Manufactureraccessdata.fda.gov
Fixative, Formalin-ContainingLDY1Manufactureraccessdata.fda.gov
Fluid, Bouin'SIGN1Manufactureraccessdata.fda.gov
Formalin, Neutral BufferedIFP1Contract manufacturer, Manufactureraccessdata.fda.gov
Formulations, Paraffin, AllKEO1Contract manufacturer, Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Contract manufacturer, Manufactureraccessdata.fda.gov
Giemsa StainHYF1Contract manufacturer, Manufactureraccessdata.fda.gov
Gold ChlorideHYH1Manufactureraccessdata.fda.gov
HematoxylinHYJ1Manufactureraccessdata.fda.gov
Hematoxylin Harris'SHYK1Manufactureraccessdata.fda.gov
Hematoxylin Mayer'SHYL1Manufactureraccessdata.fda.gov
Hematoxylin, Iron, Weigert'SIAE1Manufactureraccessdata.fda.gov
Immunohistochemistry Antibody Assay, Estrogen ReceptorMYA2Manufactureraccessdata.fda.gov
Immunohistochemistry Assay, Antibody, Progesterone ReceptorMXZ2Manufactureraccessdata.fda.gov
Immunohistochemistry Reagents And KitsNJT1Manufactureraccessdata.fda.gov
Iodine, GramsHYI1Contract manufacturer, Manufactureraccessdata.fda.gov
Iron StainsGGH1Manufactureraccessdata.fda.gov
Jenner StainKJX1Manufactureraccessdata.fda.gov
Media, Mounting, Water SolubleKEQ1Manufactureraccessdata.fda.gov
Methenamine SilverHYZ1Manufactureraccessdata.fda.gov
Methyl GreenHZA1Manufactureraccessdata.fda.gov
Methylene Blue, Tissue StainKFC1Manufactureraccessdata.fda.gov
Microtome, AccessoriesIDL1Manufacturer, Specification developeraccessdata.fda.gov
Mounting MediaLEB1Contract manufacturer, Manufactureraccessdata.fda.gov
MucicarmineHZC1Manufactureraccessdata.fda.gov
Nuclear Fast RedHZF1Manufactureraccessdata.fda.gov
Ph BufferJCC1Contract manufacturer, Manufactureraccessdata.fda.gov
Polyethylene Glycol PreservativeIFL1Manufactureraccessdata.fda.gov
Preservative, CytologicalLEA1Manufactureraccessdata.fda.gov
Reagent, SchiffHZT1Manufactureraccessdata.fda.gov
SafraninHZS1Manufactureraccessdata.fda.gov
Solution, Decalcifier, Acid ContainingKDX1Contract manufacturer, Manufactureraccessdata.fda.gov
Solution, Formol CalciumIGD1Manufactureraccessdata.fda.gov
Stain, PapanicolauHZJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Stain, ReticulocyteGJH1Manufactureraccessdata.fda.gov
Stain, Trichrome, Mallory'SHYW1Manufactureraccessdata.fda.gov
Stains, Chemical SolutionLED1Contract manufacturer, Manufactureraccessdata.fda.gov
Stains, Dye PowderLEF1Manufactureraccessdata.fda.gov
Stains, Dye SolutionLEE1Contract manufacturer, Manufactureraccessdata.fda.gov
Stains, HematologyKQC1Manufactureraccessdata.fda.gov
Stains, MicrobiologicJTS1Contract manufacturer, Manufactureraccessdata.fda.gov
Van Gieson'S StainIAC1Manufactureraccessdata.fda.gov
Wright'S StainIAF1Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 27, 2006K061360NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)MYASubstantially EquivalentLab Vision Corp.accessdata.fda.gov
April 24, 2006K060462NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)MXZSubstantially EquivalentLab Vision Corp.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 4, 201880584Class IIITerminatedEZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.Mislabeled productaccessdata.fda.gov
March 15, 201777011Class IITerminatedShandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon RapMethylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.accessdata.fda.gov
June 13, 201674557Class IITerminatedRichard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. There is the possibiliaccessdata.fda.gov
February 16, 201673334Class IIITerminatedRichard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 ParaffinMultiple complaints were received from customers indicating that they ordered product 8335(Type 3 Paraffin) but when they opened the box, they found product 8336 (Type 6 Paraffin) inside.accessdata.fda.gov
April 29, 201571178Class IITerminatedMucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimRichard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx.accessdata.fda.gov
February 19, 201570562Class IIITerminatedCarton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.accessdata.fda.gov
September 17, 201469276Class ITerminatedProtocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.The affected lots could have NBF concentrations that are lower or higher than the desired specifications.accessdata.fda.gov
August 12, 201159316Not yet classifiedTerminatedThermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.The firm has received two complaints of finger lacerations in operators of this device.accessdata.fda.gov

Compare with other makers

Updated June 27, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.