SICKLE-CELL F TEST— 510(k) K791143

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K791143 for SICKLE-CELL F TEST, Substantially Equivalent on 1979-07-17. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code KQI
Device class: Class 2
Regulation: 21 CFR 864.7455
Advisory panel: Hematology
Date received: 1979-06-18
Decision date: 1979-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KQI

K880653 — HBF DILUENT1988-04-21
K812226 — HELENA HBF QUIPLATE CONTROL1981-09-01
K810475 — HELENA HEMOGLOBIN F CONTROLS1981-03-26

More clearances from Isolab, Inc.

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K943547 — PHENYLALANINE TEST KIT1996-01-26
K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE1995-09-21
K950415 — FLUOROSCAN NEONATAL1995-09-05

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