FLOW MIC SYSTEM
FDA premarket approval N50538 · decided 1980-07-15
Approval details
- PMA number
- N50538
- Trade name
- FLOW MIC SYSTEM
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Applicant
- Flow Laboratories, Inc.
- Date received
- 1979-09-14
- Decision date
- 1980-07-15
- Days to decision
- 305 days
- Decision code
- APRL
- Product code
- LON
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Mclean, VA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| UNISKAN II (K861897) | Flow Laboratories, Inc. | 1986-07-01 |
| TITERTEK MICROPLATE WASHER S-12 (K862066) | Flow Laboratories, Inc. | 1986-06-05 |
| GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (K861824) | Flow Laboratories, Inc. | 1986-05-20 |
| GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (K861823) | Flow Laboratories, Inc. | 1986-05-20 |
| PENICILLIN-STREPTOMYCIN-FUNGIZONE (K861791) | Flow Laboratories, Inc. | 1986-05-20 |
| GAMMA-FREE HORSE SERUM (K860762) | Flow Laboratories, Inc. | 1986-03-10 |
| GOAT SERUM (29-391-54) (K860752) | Flow Laboratories, Inc. | 1986-03-10 |
| TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (K850908) | Flow Laboratories, Inc. | 1985-03-25 |