The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Phosphorus Reagent, Rapid Endpoint.
Device ID | K870776 |
510k Number | K870776 |
Device Name: | RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
Contact | Alfred E Peacock,jr |
Correspondent | Alfred E Peacock,jr REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego, CA 92111 -1203 |
Product Code | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-26 |
Decision Date | 1987-03-13 |