The following data is part of a premarket notification filed by Dade Intl., Inc. with the FDA for Paramax Ammonia And Ammonia Blank Reagent.
| Device ID | K964565 |
| 510k Number | K964565 |
| Device Name: | PARAMAX AMMONIA AND AMMONIA BLANK REAGENT |
| Classification | Enzymatic Method, Ammonia |
| Applicant | DADE INTL., INC. 9750 N.W. 25TH ST. Miami, FL 33172 |
| Contact | Marian Harding Cochran, Eqs. |
| Correspondent | Marian Harding Cochran, Eqs. DADE INTL., INC. 9750 N.W. 25TH ST. Miami, FL 33172 |
| Product Code | JIF |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-14 |
| Decision Date | 1996-11-22 |
| Summary: | summary |