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FDA 510(k)

AMNISTAT-FLM

K-Number: K822150 · 1982-10-21

ApplicantHana Biologics, Inc.
Decision Date1982-10-21
Product CodeJHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMNISTAT-FLM 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 1982-10-21 under 510(k) number K822150. 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 AMNISTAT-FLM?

AMNISTAT-FLM is a medical device that received FDA 510(k) clearance on 1982-10-21. The listed applicant is Hana Biologics, Inc.. The 510(k) number is K822150.

When did AMNISTAT-FLM receive FDA 510(k) clearance?

AMNISTAT-FLM received FDA 510(k) clearance on 1982-10-21, under 510(k) number K822150.

Who is the listed applicant for AMNISTAT-FLM?

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 AMNISTAT-FLM?

The FDA product code for AMNISTAT-FLM 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 SYSTEMK834616AMNIO STAT-FLM AGGLUTINATION TESTK833933ACE COLOR TESTK822736MYCOTRIUM-GUK822737MYCOTRIUM-RS

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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 LaboratoriesK834616AMNIO STAT-FLM AGGLUTINATION TESTHana 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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