The following data is part of a premarket notification filed by Bio Diagnostic Intl. with the FDA for Liqui-sera Chem. Multiple Calibrators.
Device ID | K853887 |
510k Number | K853887 |
Device Name: | LIQUI-SERA CHEM. MULTIPLE CALIBRATORS |
Classification | Calibrator, Secondary |
Applicant | BIO DIAGNOSTIC INTL. 1251 - Q SOUTH BEACH BLVD. La Habra, CA 90631 |
Contact | Paul Anand |
Correspondent | Paul Anand BIO DIAGNOSTIC INTL. 1251 - Q SOUTH BEACH BLVD. La Habra, CA 90631 |
Product Code | JIT |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-19 |
Decision Date | 1985-09-30 |