GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
FDA 510(k) clearance K850411 · decided 1985-05-08
Clearance details
- K-number
- K850411
- Device name
- GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
- Applicant
- Warner-Lambert Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-04
- Decision date
- 1985-05-08
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- LGP
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Morris Plains, NJ, 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 |
|---|---|---|
| IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY (K864213) | Instrumentation Laboratory CO | 1986-11-25 |
| COATEST ANTIPLASMIN (K833890) | Kabivitrum, Inc. | 1984-01-30 |
| ALPHA-ANTIPLASM ASSAY (K802840) | American Dade | 1981-02-17 |
| PROTEOLYTIC ENZYME CONTROL (K803110) | American Dade | 1981-02-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S004) | Warner-Lambert Co. | 1988-04-12 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S003) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S002) | Warner-Lambert Co. | 1986-03-17 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024/S001) | Warner-Lambert Co. | 1983-11-25 |
| AUTOBAC MTS PLUS TEST SYTEM (P810024) | Warner-Lambert Co. | 1982-03-04 |