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FDA 510(k)

FETAL MATURITY TEST PROCEDURE

K-Number: K790798 · 1979-06-05

ApplicantHelena Laboratories
Decision Date1979-06-05
Product CodeJHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FETAL MATURITY TEST PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1979-06-05 under 510(k) number K790798. 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 FETAL MATURITY TEST PROCEDURE?

FETAL MATURITY TEST PROCEDURE is a medical device that received FDA 510(k) clearance on 1979-06-05. The listed applicant is Helena Laboratories. The 510(k) number is K790798.

When did FETAL MATURITY TEST PROCEDURE receive FDA 510(k) clearance?

FETAL MATURITY TEST PROCEDURE received FDA 510(k) clearance on 1979-06-05, under 510(k) number K790798.

Who is the listed applicant for FETAL MATURITY TEST PROCEDURE?

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

What is the FDA product code for FETAL MATURITY TEST PROCEDURE?

The FDA product code for FETAL MATURITY TEST PROCEDURE is JHG.

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Other records listing Helena Laboratories as applicant

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K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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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.K822150AMNISTAT-FLMHana Biologics, Inc.K813216SECURE FDI TEST KITBeckman Instruments, Inc.K811588HELENA FETAL-TEK 200 METHODHelena 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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