The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Quik-dot Toxoplasmosis.
Device ID | K890048 |
510k Number | K890048 |
Device Name: | QUIK-DOT TOXOPLASMOSIS |
Classification | Direct Agglutination Test, Toxoplasma Gondii |
Applicant | AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
Contact | Raymond Gould |
Correspondent | Raymond Gould AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport, NJ 08014 |
Product Code | LLA |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-06 |
Decision Date | 1989-06-09 |