The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Glyco-sep/alc Test Kit For Separat Of Hemoglobin.
| Device ID | K852986 |
| 510k Number | K852986 |
| Device Name: | GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | CLINICAL TECHNOLOGY CORP. 50C ROCKY POINT RD. P.O. BOX 1723 Rocky Point, NY 11778 |
| Contact | Paul C Reiter |
| Correspondent | Paul C Reiter CLINICAL TECHNOLOGY CORP. 50C ROCKY POINT RD. P.O. BOX 1723 Rocky Point, NY 11778 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-08-19 |