510(k) K946193
- Device
- FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
- Applicant
- MORE DIAGNOSTICS
- 510(k) number
- K946193
- Product code
- GIL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-08-24
- Date received
- 1994-12-20
- Regulation
- 864.7340
- Classification name
- Plasma, Fibrinogen Control
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES W SNIPES
- Address
- P.O. Box 6714 Los Osos CA US 93412 93412
FDA Registration Numbers#
- 2032900
- 3014150341
- 1226774
- 9610806
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GIL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962407 | N/T PROTEIN CONTROL PY | Behring Diagnostics, Inc. | 1996-07-29 |
| K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | Clinical Controls, Inc. | 1995-08-24 |
| K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | Clinical Controls, Inc. | 1995-05-02 |
| K951012 | N/T PROTEIN CONTROL PY | Behring Diagnostics, Inc. | 1995-04-17 |
| K934741 | LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 | Clinical Controls, Inc. | 1994-09-08 |
| K915462 | FIBRINOGEN CONTROL | Sigma Diagnostics, Inc. | 1992-03-04 |
| K833352 | GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL | Warner-Lambert Co. | 1983-11-03 |
Legacy Summary#
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FDA Review#
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