510(k) K893885
- Device
- BACTON TM, BASIC TM, APO A-I REAGENT
- Applicant
- CATACHEM, INC.
- 510(k) number
- K893885
- Product code
- DEL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-21
- Date received
- 1989-05-30
- Regulation
- 866.5590
- Classification name
- Lipoprotein X, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE LIGGINS
- Address
- 955 Connecticut Ave. Bridgeport CT US 06606 06606
FDA Registration Numbers#
- 9610126
- 9610529
- 3006198300
- 2029372
- 3003795116
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DEL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013278 | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | Roche Diagnostics Corp. | 2001-11-15 |
| K901675 | APOLIPOPROTEIN A-I (APO A-I) | Sigma Chemical Co. | 1990-04-26 |
| K900124 | APOLIPOPROTEIN B (APO B) | Sigma Chemical Co. | 1990-03-02 |
| K895160 | ORTHO *APO A-1 ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | 1989-10-06 |
Legacy Summary#
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FDA Review#
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