SICKLE CELL SOLUBILITY TEST KIT— 510(k) K895745

Substantially Equivalent

Simmler, Inc.

FDA 510(k) clearance K895745 for SICKLE CELL SOLUBILITY TEST KIT, Substantially Equivalent on 1989-11-29. Applicant: Simmler, Inc.. Device class: 2.

Clearance details

Applicant: Simmler, Inc.
Product code: Code JBB
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1989-09-26
Decision date: 1989-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JBB

K932872 — SICKLE CELL TEST KIT1993-08-16

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K874311 — MULTICHEM (R) TOTAL BILIRUBIN1987-11-25

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