AMES TDA TM PHENOBARBITAL TEST
FDA 510(k) clearance K810994 · decided 1981-04-29
Clearance details
- K-number
- K810994
- Device name
- AMES TDA TM PHENOBARBITAL TEST
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-13
- Decision date
- 1981-04-29
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- LET
- Device class
- 2
- Regulation number
- 862.3660
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Walker, MI, 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 |
|---|---|---|
| MODIFIED OPUS PHENOBARBITAL TEST SYSTEM (K901537) | Pb Diagnostic Systems, Inc. | 1990-06-12 |
| IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS (K865000) | Sclavo, Inc. | 1987-02-06 |
| AMES TDA PHENOBARBITAL TEST (K842592) | Miles Laboratories, Inc. | 1984-08-17 |
| STRATUS PHENOBARBITAL FLUOROMETRIC ENZ (K830701) | American Dade | 1983-05-13 |
| PHENOBARBITAL FLUORESCENT IMMUNO (K821408) | American Diagnostic Corp. | 1982-05-24 |
| PHENOBARBITAL ASSAY (K820188) | Syva Co. | 1982-02-05 |
| AMES TDA PHENOBARBITAL TEST (K802255) | Miles Laboratories, Inc. | 1980-09-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |