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FDA 510(k)

ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE

K-Number: K992397 · 1999-08-26

ApplicantCenogenics Corp.
Decision Date1999-08-26
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Cenogenics Corp.. It received FDA 510(k) clearance on 1999-08-26 under 510(k) number K992397. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE?

ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE is a medical device that received FDA 510(k) clearance on 1999-08-26. The listed applicant is Cenogenics Corp.. The 510(k) number is K992397.

When did ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE receive FDA 510(k) clearance?

ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE received FDA 510(k) clearance on 1999-08-26, under 510(k) number K992397.

Who is the listed applicant for ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE?

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

What is the FDA product code for ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE?

The FDA product code for ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE is JHI.

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Other records listing Cenogenics Corp. 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.

K042641CHEMVIEW-10K030533ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TESTK894793MONODEXK843680URI-VAL

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Official Source

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

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