FDA product code GRZ: Antisera, Fluorescent, All, Mycoplasma Spp.
GRZ is the FDA product code for antisera, fluorescent, all, mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under GRZ, from 4 different applicants. The average 510(k) review took 268 days (median 329).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All, Mycoplasma Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3375 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GRZ clearance
Top GRZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 2 | 1996-02-07 |
| Fuller Laboratories, Inc. | 1 | 1994-03-11 |
| Whittaker Bioproducts, Inc. | 1 | 1986-08-08 |
| Zeus Technologies | 1 | 1984-02-27 |
Most recent GRZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K946373 | Zeus Scientific, Inc. | MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM | 1996-02-07 | 518 |
| K944417 | Zeus Scientific, Inc. | ZEUA MYCOPLASMA | 1995-08-01 | 329 |
| K931557 | Fuller Laboratories, Inc. | FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST | 1994-03-11 | 346 |
| K861716 | Whittaker Bioproducts, Inc. | FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY | 1986-08-08 | 94 |
| K840012 | Zeus Technologies | INDIRECT FLUORESCENT ANTIBODY MYCO | 1984-02-27 | 54 |
Recalls for GRZ devices
openFDA lists no recalls for product code GRZ.
Frequently asked questions
What is FDA product code GRZ?
GRZ is the FDA product code for antisera, fluorescent, all, mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel.
What device class is GRZ?
Class I, regulation 21 CFR 866.3375. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRZ?
Across 5 cleared submissions the average was 268 days from receipt to decision (median 329).
Which companies have the most GRZ clearances?
Zeus Scientific, Inc. (2); Fuller Laboratories, Inc. (1); Whittaker Bioproducts, Inc. (1); Zeus Technologies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRZ
- Run a recall and safety report across every GRZ manufacturer
- Watch product code GRZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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