The following data is part of a premarket notification filed by Quest Intl., Inc. with the FDA for Anti-cardiolipin, Multiple Autoantibodies Immunological Test System.
Device ID | K003069 |
510k Number | K003069 |
Device Name: | ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM |
Classification | System, Test, Anticardiolipin Immunological |
Applicant | QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami, FL 33181 |
Contact | Robert A Cort |
Correspondent | Robert A Cort QUEST INTL., INC. 1938 N.E. 148TH TERR. North Miami, FL 33181 |
Product Code | MID |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-02 |
Decision Date | 2000-11-27 |