The following data is part of a premarket notification filed by Bayer Corp. with the FDA for New Multiples Reagent Strips.
Device ID | K992257 |
510k Number | K992257 |
Device Name: | NEW MULTIPLES REAGENT STRIPS |
Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
Applicant | BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
Contact | Syed Ataullah |
Correspondent | Syed Ataullah BAYER CORP. 1884 MILES AVE. Elkhart, IN 46514 |
Product Code | JIR |
Subsequent Product Code | CDM |
Subsequent Product Code | CEN |
Subsequent Product Code | JFY |
Subsequent Product Code | JIL |
Subsequent Product Code | JIN |
Subsequent Product Code | JIO |
Subsequent Product Code | JJB |
Subsequent Product Code | JMT |
Subsequent Product Code | JRE |
Subsequent Product Code | LJX |
CFR Regulation Number | 862.1645 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-06 |
Decision Date | 1999-11-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630414551142 | K992257 | 000 |
00630414549019 | K992257 | 000 |
00630414549026 | K992257 | 000 |
00630414549033 | K992257 | 000 |
00630414549040 | K992257 | 000 |
00630414549057 | K992257 | 000 |
00630414549118 | K992257 | 000 |
00630414549125 | K992257 | 000 |
00630414549132 | K992257 | 000 |
00630414549255 | K992257 | 000 |
00630414549262 | K992257 | 000 |
00630414550602 | K992257 | 000 |
00630414551111 | K992257 | 000 |
00630414548968 | K992257 | 000 |