The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Calcium Chloride/diethylbarb Acetate Buff Solution.
| Device ID | K924509 |
| 510k Number | K924509 |
| Device Name: | CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | Joseph Kiceina |
| Correspondent | Joseph Kiceina BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-04 |
| Decision Date | 1992-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768014222 | K924509 | 000 |
| 00842768018916 | K924509 | 000 |