Skip to the page

Data / Medical devices / United States / Kent Laboratories, Inc.

Kent Laboratories, Inc.: FDA-registered device maker in Bellingham, WA, United States, 18 510(k) clearances

Kent Laboratories, Inc. is registered with the FDA (registration 3019906) in Bellingham, WA, United States. It lists 59 device types. The FDA files 18 510(k) clearances under its listings, the newest dated June 1, 1995. Registered through 2027. 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.

FDA registration number
3019906
Address
777 Jorgensen Pl, Bellingham, WA, United States, 98226
Owner or operator
KENT LABORATORIES, INC. (3019906)
Roles
Manufacturer
First device listed
December 15, 1992
Registered through
2027
Brand names listed
ALPHA-1-ACID-GLYCOPROTEIN ANTISERUM, ANTI HUMAN HEMOPEXIN ANTISERUM, ANTISERUM TO HAPTOGLOBIN, ANTISERUM TO PREALBUMIN, Antiserum to C3 Proactivator (Factor B), Antiserum to Goat IgG, Antiserum to Human Albumin, Antiserum to Human Alpha 1 Acidglycoprotein and more

Devices it lists

DeviceProduct codeClassRoleSource
Albumin, Antigen, Antiserum, ControlDCF2Manufactureraccessdata.fda.gov
Albumin, Fitc, Antigen, Antiserum, ControlDDZ2Manufactureraccessdata.fda.gov
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlLKL1Manufactureraccessdata.fda.gov
Alpha-1-Antitrypsin, Antigen, Antiserum, ControlDEM2Manufactureraccessdata.fda.gov
Alpha-1-B-Glycoprotein, Antigen, Antiserum, ControlDEX1Manufactureraccessdata.fda.gov
Alpha-2-Macroglobulin, Antigen, Antiserum, ControlDEB2Manufactureraccessdata.fda.gov
Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, ControlDDY2Manufactureraccessdata.fda.gov
Antithrombin Iii QuantitationJBQ2Manufactureraccessdata.fda.gov
ApolipoproteinsMSJ1Manufactureraccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Manufactureraccessdata.fda.gov
Ceruloplasmin, Antigen, Antiserum, ControlDDB2Manufactureraccessdata.fda.gov
Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, ControlDBA2Manufactureraccessdata.fda.gov
Complement C1q, Antigen, Antiserum, ControlDAK2Manufactureraccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Manufactureraccessdata.fda.gov
Complement C3b Activator, Antigen, Antiserum, ControlDAC2Manufactureraccessdata.fda.gov
Complement C4, Antigen, Antiserum, ControlDBI2Manufactureraccessdata.fda.gov
Complement C5, Antigen, Antiserum, ControlDAY2Manufactureraccessdata.fda.gov
Fab, Fitc, Antigen, Antiserum, ControlDCB1Manufactureraccessdata.fda.gov
Fab, Rhodamine, Antigen, Antiserum, ControlDBY1Manufactureraccessdata.fda.gov
Factor B, Antigen, Antiserum, ControlJZH2Manufactureraccessdata.fda.gov
Fc, Antigen, Antiserum, ControlDBN1Manufactureraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Manufactureraccessdata.fda.gov
Fibrinogen And Split Products, Antigen, Antiserum, ControlDAZ2Manufactureraccessdata.fda.gov
Fibrinogen And Split Products, Fitc, Antigen, Antiserum, ControlDAX2Manufactureraccessdata.fda.gov
Haptoglobin, Antigen, Antiserum, ControlDAD2Manufactureraccessdata.fda.gov
Hemopexin, Antigen, Antiserum, ControlCZX2Manufactureraccessdata.fda.gov
Iga, Antigen, Antiserum, ControlCZP2Manufactureraccessdata.fda.gov
Iga, Fitc, Antigen, Antiserum, ControlCZN2Manufactureraccessdata.fda.gov
Iga, Peroxidase, Antigen, Antiserum, ControlCZL2Manufactureraccessdata.fda.gov
Iga, Rhodamine, Antigen, Antiserum, ControlCZK2Manufactureraccessdata.fda.gov
Igd, Antigen, Antiserum, ControlCZJ2Manufactureraccessdata.fda.gov
Igd, Fitc, Antigen, Antiserum, ControlDGG2Manufactureraccessdata.fda.gov
Igd, Rhodamine, Antigen, Antiserum, ControlDGE2Manufactureraccessdata.fda.gov
Ige, Fitc, Antigen, Antiserum, ControlDGP2Manufactureraccessdata.fda.gov
Igg (Fab Fragment Specific), Antigen, Antiserum, ControlDFK1Manufactureraccessdata.fda.gov
Igg (Fc Fragment Specific), Antigen, Antiserum, ControlDAS1Manufactureraccessdata.fda.gov
Igg (Gamma Chain Specific), Antigen, Antiserum, ControlDFZ2Manufactureraccessdata.fda.gov
Igg, Antigen, Antiserum, ControlDEW2Manufactureraccessdata.fda.gov
Igg, Fitc, Antigen, Antiserum, ControlDGK2Manufactureraccessdata.fda.gov
Igg, Peroxidase, Antigen, Antiserum, ControlDAA2Manufactureraccessdata.fda.gov
Igg, Rhodamine, Antigen, Antiserum, ControlDFO2Manufactureraccessdata.fda.gov
Igm (Mu Chain Specific), Antigen, Antiserum, ControlDAO2Manufactureraccessdata.fda.gov
Igm, Fitc, Antigen, Antiserum, ControlDFS2Manufactureraccessdata.fda.gov
Igm, Peroxidase, Antigen, Antiserum, ControlDEY2Manufactureraccessdata.fda.gov
Igm, Rhodamine, Antigen, Antiserum, ControlDEZ2Manufactureraccessdata.fda.gov
Immunoelectrophoretic, Immunoglobulins, (G, A, M)CFF2Manufactureraccessdata.fda.gov
Kappa, Antigen, Antiserum, ControlDFH2Manufactureraccessdata.fda.gov
Kappa, Fitc, Antigen, Antiserum, ControlDEO2Manufactureraccessdata.fda.gov
Kappa, Rhodamine, Antigen, Antiserum, ControlDEK2Manufactureraccessdata.fda.gov
Lambda, Antigen, Antiserum, ControlDEH2Manufactureraccessdata.fda.gov
Lambda, Fitc, Antigen, Antiserum, ControlDES2Manufactureraccessdata.fda.gov
Method, Immunodiffusion, Immunoglobulins (G, A, M)CGM2Manufactureraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Manufactureraccessdata.fda.gov
Plates And Equipment, Radial ImmunodiffusionJZQ1Manufactureraccessdata.fda.gov
Prealbumin, Antigen, Antiserum, ControlJZJ1Manufactureraccessdata.fda.gov
Protein, Complement, Antigen, Antiserum, ControlDHL1Manufactureraccessdata.fda.gov
Radial Immunodiffusion, LipoproteinsJHP1Manufactureraccessdata.fda.gov
Transferrin, Antigen, Antiserum, ControlDDG2Manufactureraccessdata.fda.gov
Whole Human Serum, Antigen, Antiserum, ControlDGR1Manufactureraccessdata.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 1, 1995K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITJZJSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
May 30, 1995K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITDAKSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
May 30, 1995K951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITDBASubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
April 10, 1995K950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITDAYSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
November 27, 1985K85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2DEBSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
November 25, 1985K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPLDDBSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
November 1, 1985K850691ANTISERUM TO HUMAN APOLIPOPROTEIN A-IMSJSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
November 1, 1985K850690ANTISERUM TO HUMAN APOLIPOPROTEIN BMSJSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
November 1, 1985K850686ANTISERUM TO HUMAN PREALBUMINJZJSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
August 11, 1983K831961IMMUNODIFFUSION TEST HUMAN ANTITHROMBINJBQSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
July 19, 1983K831960TEST FOR HUMAN ALPHA ONE ACID GLYCO-LKLSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
July 19, 1983K831959RADIAL IMMUNO-TEST FOR HUMAN FACTOR BJZHSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
July 19, 1983K831958RADIAL IMMUNO-TEST FOR HUMAN C-REACTIDCKSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
July 18, 1983K831957DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOBDADSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
December 30, 1982K823765ANTI SERA TO HUMAN OROSCOMUCOIDDEXSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
August 12, 1981K81161372 DETERMIN. SIZE RADIAL IMMUNOD. TESTDDGSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
August 16, 1979K790714ANTISERUM TO HUMAN CERULOPLASMINDDBSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov
August 3, 1977K771242ANTISERA TO HUMAN FAB FRAGMENTDDRSubstantially EquivalentKent Laboratories, Inc.accessdata.fda.gov

Compare with other makers

Updated June 1, 1995. 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.