GRZ
5 FDA 510(k) clearances · Product code
329 daysmedian time to decision
518 days90th percentile
5clearances measured
FDA profile
- Official device name
- Antisera, Fluorescent, All, Mycoplasma Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3375
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM (K946373) | Zeus Scientific, Inc. | 1996-02-07 |
| ZEUA MYCOPLASMA (K944417) | Zeus Scientific, Inc. | 1995-08-01 |
| FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST (K931557) | Fuller Laboratories, Inc. | 1994-03-11 |
| FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY (K861716) | Whittaker Bioproducts, Inc. | 1986-08-08 |
| INDIRECT FLUORESCENT ANTIBODY MYCO (K840012) | Zeus Technologies | 1984-02-27 |
Track GRZ automatically
Every clearance here is in the API, with alerts when new ones post.