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 |