The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Vitamin B12 (lkvb1,lkvb5).
| Device ID | K971177 |
| 510k Number | K971177 |
| Device Name: | IMMULITE VITAMIN B12 (LKVB1,LKVB5) |
| Classification | Radioassay, Vitamin B12 |
| 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 | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964874 | K971177 | 000 |
| 00630414954448 | K971177 | 000 |