The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Pda699/pda700 Protamine Dose Assay For Hep. Neutra.
| Device ID | K870831 |
| 510k Number | K870831 |
| Device Name: | PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Michael D Mintz |
| Correspondent | Michael D Mintz INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234101230 | K870831 | 000 |