510(k) K803110
- Device
- Proteolytic Enzyme Control
- Applicant
- AMERICAN DADE
- 510(k) number
- K803110
- Product code
- LGP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-02-17
- Date received
- 1980-12-10
- Regulation
- 864.5425
- Classification name
- Assay, Alpha-2-Antiplasmin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K850411 | GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY | Warner-Lambert Co. | 1985-05-08 |
| K833890 | COATEST ANTIPLASMIN | Kabivitrum, Inc. | 1984-01-30 |
| K802840 | ALPHA-ANTIPLASM ASSAY | American Dade | 1981-02-17 |