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 |