Hamilton-Thorn Motility Analyzer HTM-2000

FDA 510(k) K873172 · Hamilton Thorne Research

Substantially Equivalent

510(k) numberK873172

Submission

Device name
Hamilton-Thorn Motility Analyzer HTM-2000
Applicant
Hamilton Thorne Research
Danvers, MA, US
Received
August 11, 1987
Decision date
November 6, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GKL – Counter, Cell, Automated (Particle Counter)
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5200
Specialty
Hematology

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K001683Sysmex R-500GKL · Traditional Sysmex Corporation of America08/21/2000SE
K991070Coulter Z2 AnalyzerGKL · Traditional Coulter Corp.05/11/1999SE
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Questions and answers

When was Hamilton-Thorn Motility Analyzer HTM-2000 cleared by the FDA?

Hamilton-Thorn Motility Analyzer HTM-2000 (K873172) received a 510(k) decision of Substantially Equivalent on November 6, 1987, 87 days after the submission was received.

What is the product code of K873172?

The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.