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FDA 510(k)

AUTOMARQER

K-Number: K990184 · 1999-03-19

ApplicantHamilton Thorne Research
Decision Date1999-03-19
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOMARQER is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne Research. It received FDA 510(k) clearance on 1999-03-19 under 510(k) number K990184. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMARQER?

AUTOMARQER is a medical device that received FDA 510(k) clearance on 1999-03-19. The listed applicant is Hamilton Thorne Research. The 510(k) number is K990184.

When did AUTOMARQER receive FDA 510(k) clearance?

AUTOMARQER received FDA 510(k) clearance on 1999-03-19, under 510(k) number K990184.

Who is the listed applicant for AUTOMARQER?

The FDA 510(k) record lists Hamilton Thorne Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMARQER?

The FDA product code for AUTOMARQER is POV.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Hamilton Thorne Research as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012805AUTOMARQERK000380FOTOMASTERK920719IVOS ANALYZERK873172HAMILTON-THORN MOTILITY ANALYZER HTM-2000

Related Devices (Code: POV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252228Seaman Pro/SeamanCheckcells, Inc.K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd.K243114SQA-iOw Sperm Quality AnalyzerMedical Electronic Systems , Ltd.K241628YO Home Sperm TestMedical Electronic Systems , Ltd.K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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