The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Pyrilinks-d Model Numbers Lkpd1, Lkpd5.
| Device ID | K980833 |
| 510k Number | K980833 |
| Device Name: | IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 |
| 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 | 1998-03-04 |
| Decision Date | 1998-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964416 | K980833 | 000 |
| 00630414961859 | K980833 | 000 |
| 00630414954202 | K980833 | 000 |
| 00630414953281 | K980833 | 000 |