The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Hemocard, Hemoglobin C Assay.
Device ID | K923153 |
510k Number | K923153 |
Device Name: | HEMOCARD, HEMOGLOBIN C ASSAY |
Classification | Hemoglobin C (abnormal Hemoglobin Variant) |
Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
Contact | Janet D Perkins |
Correspondent | Janet D Perkins ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
Product Code | MLL |
CFR Regulation Number | 864.7415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-29 |
Decision Date | 1994-01-27 |