U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)

Whole Blood Hemoglobin Determination

U. S. DIAGNOSTICS, INC.

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).

Pre-market Notification Details

Device IDK862641
510k NumberK862641
Device Name:U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
ClassificationWhole Blood Hemoglobin Determination
Applicant U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
ContactRoy E Speck
CorrespondentRoy E Speck
U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo,  CA  93401
Product CodeKHG  
CFR Regulation Number864.7500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-11
Decision Date1986-08-21

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