The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Tinaquant B 2-microglobulin Assay.
| Device ID | K980724 |
| 510k Number | K980724 |
| Device Name: | TINAQUANT B 2-MICROGLOBULIN ASSAY |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Contact | Julie Lingenfelter |
| Correspondent | Julie Lingenfelter BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-24 |
| Decision Date | 1998-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630928781 | K980724 | 000 |
| 04015630900152 | K980724 | 000 |