ANTIBIOTIC MEDIUM #19
FDA 510(k) clearance K881537 · decided 1988-04-18
Clearance details
- K-number
- K881537
- Device name
- ANTIBIOTIC MEDIUM #19
- Applicant
- Acumedia Manufacturers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-04-08
- Decision date
- 1988-04-18
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- JSA
- Device class
- 1
- Regulation number
- 866.2350
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Baltimore, MD, 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 |
|---|---|---|
| ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR (K881534) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR (K881536) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR (K881538) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| ANTIBIOTIC MEDIUM #6 (K881535) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| SEED AGAR (K832577) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| BASE AGAR (K832576) | Acumedia Manufacturers, Inc. | 1983-09-12 |
| ANTIBIOTIC ASSAY BROTH (K832575) | Acumedia Manufacturers, Inc. | 1983-09-12 |
Recalls involving this device
No recalls on record reference this clearance.