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 |