Chemstrip L

FDA 510(k) K811189 · Biodynamics Corp.

Substantially Equivalent

510(k) numberK811189

Submission

Device name
Chemstrip L
Applicant
Biodynamics Corp.
Mchenry, IL, US
Received
April 29, 1981
Decision date
July 27, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GHD – Test, Leukocyte Alkaline Phosphatase
Device class
Class I (low risk)
Regulation
21 CFR 864.7660
Specialty
Hematology

Other 510(k)s with product code GHD

510(k)DeviceApplicantDecision
K904022Nitro Blue Tetrazolium ReductionGHD · Traditional Sigma Chemical Co.12/18/1990SE
K903995Naphthol As-D Chlor/A-Naphthyl Acet Esterase KitGHD · Traditional Sigma Chemical Co.12/13/1990SE
K896092Alkaline Phosphatase, Leukocyte, KitGHD · Traditional Sigma Chemical Co.11/09/1989SE

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K874034ADR-22 Automatic Dialyzer ReprocessorLIF · Traditional 10/23/1987SE
K870052Infumix Mixing ContainerKPE · Traditional 02/27/1987SE
K822716Universal CentrifugeJPI · Traditional 09/30/1982SE
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Questions and answers

When was Chemstrip L cleared by the FDA?

Chemstrip L (K811189) received a 510(k) decision of Substantially Equivalent on July 27, 1981, 89 days after the submission was received.

What is the product code of K811189?

The FDA product code is GHD – Test, Leukocyte Alkaline Phosphatase, a Class I (low risk) device regulated under 21 CFR 864.7660.