The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Dade Moni-trol Candidate Product Combinations.
| Device ID | K960103 |
| 510k Number | K960103 |
| Device Name: | DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DADE INTL., INC. 9750 N.W. 25TH ST. Miami, FL 33172 |
| Contact | Marian Harding-cochran |
| Correspondent | Marian Harding-cochran DADE INTL., INC. 9750 N.W. 25TH ST. Miami, FL 33172 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-04-26 |
| Summary: | summary |