The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Sickle Hemoglobin (hba/s) Control Set.
Device ID | K913427 |
510k Number | K913427 |
Device Name: | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET |
Classification | Control, Hemoglobin, Abnormal |
Applicant | CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
Contact | Gary J Proksch |
Correspondent | Gary J Proksch CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
Product Code | JCM |
CFR Regulation Number | 864.7415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-01 |
Decision Date | 1991-11-19 |