The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for U.s. Diagnostic Inc. Hemoglobin Test (dry Pack).
Device ID | K862641 |
510k Number | K862641 |
Device Name: | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) |
Classification | Whole Blood Hemoglobin Determination |
Applicant | U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
Contact | Roy E Speck |
Correspondent | Roy E Speck U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
Product Code | KHG |
CFR Regulation Number | 864.7500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-11 |
Decision Date | 1986-08-21 |