The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Tina-quant Microalbumin.
| Device ID | K932950 |
| 510k Number | K932950 |
| Device Name: | TINA-QUANT MICROALBUMIN |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | John Stevens |
| Correspondent | John Stevens BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-17 |
| Decision Date | 1995-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630936410 | K932950 | 000 |
| 04015630923410 | K932950 | 000 |
| 04015630920587 | K932950 | 000 |