The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Inorganic Phosphorus Liquid Stable Reagent Inorgan.
Device ID | K852103 |
510k Number | K852103 |
Device Name: | INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
Contact | Donna L Anderson |
Correspondent | Donna L Anderson MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-15 |
Decision Date | 1985-05-31 |