FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
FDA 510(k) clearance K931557 · decided 1994-03-11
Clearance details
- K-number
- K931557
- Device name
- FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
- Applicant
- Fuller Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-30
- Decision date
- 1994-03-11
- Days to decision
- 346 days
- Clearance type
- Traditional
- Product code
- GRZ
- Device class
- 1
- Regulation number
- 866.3375
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Fullerton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.