Data / Medical devices / United States / Greer Laboratories, Inc.
Greer Laboratories, Inc.: FDA-registered device maker in Lenoir, NC, United States, 1 510(k) clearance
Greer Laboratories, Inc. is registered with the FDA (registration 1011574) in Lenoir, NC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 23, 1989. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1011574
- Address
- 639 Nuway Circle, N.E., Lenoir, NC, United States, 28645
- Owner or operator
- GREER LABORATORIES, INC. (1011574)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 16, 2007
- Registered through
- 2026
- Brand names listed
- GREER Dia-Kit, GREERPick System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Allergen And Vaccine Delivery Needles | SCL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Test, Hypersensitivity Pneumonitis | DGW | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 1989 | K890360 | GREER DERMAPIK SYSTEM | SCL | Substantially Equivalent | Greer Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 25, 2022 | 91078 | Class II | Terminated | GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies. | The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined | accessdata.fda.gov |
| January 28, 2005 | 31166 | Not yet classified | Terminated | Sterile Empty Vials for Allergenic Extracts, 100ml size | Product may not be sterile. | accessdata.fda.gov |
Compare with other makers
Updated November 30, 2022. 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.