The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Sickle-stat Hemoglobin S Screen Kit.
Device ID | K841272 |
510k Number | K841272 |
Device Name: | SICKLE-STAT HEMOGLOBIN S SCREEN KIT |
Classification | Test, Sickle Cell |
Applicant | CLINICAL TECHNOLOGY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GHM |
CFR Regulation Number | 864.7825 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-27 |
Decision Date | 1984-04-13 |