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FDA 510(k)

AMNIO STAT-FLM AGGLUTINATION TEST

K-Number: K834616 · 1984-05-25

ApplicantHana Biologics, Inc.
Decision Date1984-05-25
Product CodeJHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMNIO STAT-FLM AGGLUTINATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hana Biologics, Inc.. It received FDA 510(k) clearance on 1984-05-25 under 510(k) number K834616. The device is classified under product code JHG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNIO STAT-FLM AGGLUTINATION TEST?

AMNIO STAT-FLM AGGLUTINATION TEST is a medical device that received FDA 510(k) clearance on 1984-05-25. The listed applicant is Hana Biologics, Inc.. The 510(k) number is K834616.

When did AMNIO STAT-FLM AGGLUTINATION TEST receive FDA 510(k) clearance?

AMNIO STAT-FLM AGGLUTINATION TEST received FDA 510(k) clearance on 1984-05-25, under 510(k) number K834616.

Who is the listed applicant for AMNIO STAT-FLM AGGLUTINATION TEST?

The FDA 510(k) record lists Hana Biologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMNIO STAT-FLM AGGLUTINATION TEST?

The FDA product code for AMNIO STAT-FLM AGGLUTINATION TEST is JHG.

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Other records listing Hana Biologics, Inc. 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.

K883682CHANG MEDIUM (ADDITIONAL INDICATIONS)K855205MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEMK833933ACE COLOR TESTK822737MYCOTRIUM-RSK822736MYCOTRIUM-GUK822150AMNISTAT-FLM

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Related Devices (Code: JHG)

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.

K061549AMNIOSTAT-FLM-PGIrvine Scientific Sales Co., Inc.K871593TDXR FETAL LUNG MATURITYAbbott LaboratoriesK822150AMNISTAT-FLMHana Biologics, Inc.K813216SECURE FDI TEST KITBeckman Instruments, Inc.K811588HELENA FETAL-TEK 200 METHODHelena LaboratoriesK790798FETAL MATURITY TEST PROCEDUREHelena Laboratories

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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