The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite(r) Tbg.
| Device ID | K950072 |
| 510k Number | K950072 |
| Device Name: | IMMULITE(R) TBG |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-09 |
| Decision Date | 1995-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964652 | K950072 | 000 |
| 00630414962078 | K950072 | 000 |
| 00630414954271 | K950072 | 000 |
| 00630414953298 | K950072 | 000 |