The following data is part of a premarket notification filed by Primus Corp. with the FDA for Primus Liquid Control For Ghb/alc Level I And Level Ii.
Device ID | K992921 |
510k Number | K992921 |
Device Name: | PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II |
Classification | Assay, Glycosylated Hemoglobin |
Applicant | PRIMUS CORP. P.O. BOX 22599 Kansas City, MO 64113 |
Contact | Jimmie K Noffsinger |
Correspondent | Jimmie K Noffsinger PRIMUS CORP. P.O. BOX 22599 Kansas City, MO 64113 |
Product Code | LCP |
CFR Regulation Number | 864.7470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-30 |
Decision Date | 1999-11-12 |
Summary: | summary |