The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite/immulite 1000 Calcitonin, Model Lkcl And Immulite 2000 Calcitonin, Model L2kcl.
| Device ID | K023304 |
| 510k Number | K023304 |
| Device Name: | IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL |
| Classification | Radioimmunoassay, Calcitonin |
| 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 | JKR |
| CFR Regulation Number | 862.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-03 |
| Decision Date | 2002-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963730 | K023304 | 000 |
| 00630414961156 | K023304 | 000 |
| 00630414953618 | K023304 | 000 |
| 00630414953120 | K023304 | 000 |