510(k) K833890
- Device
- COATEST ANTIPLASMIN
- Applicant
- KABIVITRUM, INC.
- 510(k) number
- K833890
- Product code
- LGP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-01-30
- Date received
- 1983-11-09
- 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
- Anaheim CA US
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 |
| K802840 | ALPHA-ANTIPLASM ASSAY | American Dade | 1981-02-17 |
| K803110 | PROTEOLYTIC ENZYME CONTROL | American Dade | 1981-02-17 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases