The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Hemocard Control Hb-aa, Ae, Faa, Fae.
Device ID | K931234 |
510k Number | K931234 |
Device Name: | HEMOCARD CONTROL HB-AA, AE, FAA, FAE |
Classification | Control, Hemoglobin, Abnormal |
Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
Contact | Janet Perkins |
Correspondent | Janet Perkins ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
Product Code | JCM |
CFR Regulation Number | 864.7415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-10 |
Decision Date | 1993-05-11 |