CHEMSTRIP L— 510(k) K811189

Substantially Equivalent

Biodynamics Corp.

FDA 510(k) clearance K811189 for CHEMSTRIP L, Substantially Equivalent on 1981-07-27. Applicant: Biodynamics Corp.. Device class: 1.

Clearance details

Applicant: Biodynamics Corp.
Product code: Code GHD
Device class: Class 1
Regulation: 21 CFR 864.7660
Advisory panel: Hematology
Date received: 1981-04-29
Decision date: 1981-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GHD

K904022 — NITRO BLUE TETRAZOLIUM REDUCTION1990-12-18
K903995 — NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT1990-12-13
K896092 — ALKALINE PHOSPHATASE, LEUKOCYTE, KIT1989-11-09

More clearances from Biodynamics Corp.

K051675 — BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER2006-03-16
K884033 — BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER1988-11-17
K881631 — BIODYNAMICS AUTOTRANSFUSION RESERVOIR1988-09-09
K881968 — BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER1988-07-28
K874361 — BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER1988-03-16

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