AUTOBAC MTS PLUS TEST SYTEM
FDA premarket approval P810024/S002 · decided 1986-03-17
Approval details
- PMA number
- P810024
- Supplement
- S002
- Trade name
- AUTOBAC MTS PLUS TEST SYTEM
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Applicant
- Warner-Lambert Co.
- Date received
- 1985-10-15
- Decision date
- 1986-03-17
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- LON
- Advisory committee
- Microbiology
- Expedited review
- No
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NEOSPORIN SCAR SOLUTION (K024160) | Warner-Lambert Co. | 2003-03-17 |
| EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM (K893452) | Warner-Lambert Co. | 1989-06-22 |
| O.P.T.(TM) OVULATION PREDICTION TEST (K870584) | Warner-Lambert Co. | 1987-11-25 |
| MULTILUMEN VIAPIC CENTRAL LINE CATHETER (K861510) | Warner-Lambert Co. | 1986-06-09 |
| GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (K852967) | Warner-Lambert Co. | 1985-08-19 |
| GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK (K852689) | Warner-Lambert Co. | 1985-08-19 |
| GENERAL DIAGNOSTICS COAG-A-MATE XC (K852843) | Warner-Lambert Co. | 1985-08-13 |
| GENERAL DIAGNOSTICS RAPID E. COLI TEST (K852889) | Warner-Lambert Co. | 1985-07-23 |