HEMOGLOBIN— 510(k) K883683

Substantially Equivalent

Tech-Co, Inc.

FDA 510(k) clearance K883683 for HEMOGLOBIN, Substantially Equivalent on 1988-10-06. Applicant: Tech-Co, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Co, Inc.
Product code: Code GJZ
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1988-08-29
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Park, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJZ

K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN1988-04-21

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Data sourced from openFDA. This site is unofficial and independent of the FDA.