The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Pyrilinks-d.
| Device ID | K971312 |
| 510k Number | K971312 |
| Device Name: | IMMULITE PYRILINKS-D |
| Classification | Column Chromatography & Color Development, Hydroxyproline |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JMM |
| CFR Regulation Number | 862.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-09 |
| Decision Date | 1997-05-27 |
| Summary: | summary |