GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL
FDA 510(k) clearance K833352 · decided 1983-11-03
Clearance details
- K-number
- K833352
- Device name
- GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL
- Applicant
- Warner-Lambert Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-28
- Decision date
- 1983-11-03
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- GIL
- Device class
- 2
- Regulation number
- 864.7340
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| N/T PROTEIN CONTROL PY (K962407) | Behring Diagnostics, Inc. | 1996-07-29 |
| FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (K946265) | Clinical Controls, Inc. | 1995-08-24 |
| FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 (K946193) | More Diagnostics | 1995-08-24 |
| PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (K935598) | Clinical Controls, Inc. | 1995-05-02 |
| N/T PROTEIN CONTROL PY (K951012) | Behring Diagnostics, Inc. | 1995-04-17 |
| LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 (K934741) | Clinical Controls, Inc. | 1994-09-08 |
| FIBRINOGEN CONTROL (K915462) | Sigma Diagnostics, Inc. | 1992-03-04 |
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 |