510(k) K850411
- Device
- GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
- Applicant
- WARNER-LAMBERT CO.
- 510(k) number
- K850411
- Product code
- LGP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-05-08
- Date received
- 1985-02-04
- Regulation
- 864.5425
- Classification name
- Assay, Alpha-2-antiplasmin
- Medical specialty
- Hematology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN DECARO
- Address
- 201 Tabor Rd. Morris Plains NJ US 07950 07950
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LGP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K864213 | IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY | Instrumentation Laboratory CO | 1986-11-25 |
| K833890 | COATEST ANTIPLASMIN | Kabivitrum, Inc. | 1984-01-30 |
| K802840 | ALPHA-ANTIPLASM ASSAY | American Dade | 1981-02-17 |
| K803110 | PROTEOLYTIC ENZYME CONTROL | American Dade | 1981-02-17 |
Legacy Summary#
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FDA Review#
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