The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Reptilase -pc.
| Device ID | K843207 |
| 510k Number | K843207 |
| Device Name: | REPTILASE -PC |
| Classification | Bothrops Atrox Reagent |
| Applicant | BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Contact | James W Eichelberge |
| Correspondent | James W Eichelberge BIO/DATA CORP. 3615 DAVISVILLE RD. P.O. BOX 250 Hatboro, PA 19040 |
| Product Code | JCO |
| CFR Regulation Number | 864.8100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-15 |
| Decision Date | 1984-10-23 |