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FDA 510(k)

TDXR FETAL LUNG MATURITY

K-Number: K871593 · 1987-07-20

ApplicantAbbott Laboratories
Decision Date1987-07-20
Product CodeJHG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TDXR FETAL LUNG MATURITY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1987-07-20 under 510(k) number K871593. 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 TDXR FETAL LUNG MATURITY?

TDXR FETAL LUNG MATURITY is a medical device that received FDA 510(k) clearance on 1987-07-20. The listed applicant is Abbott Laboratories. The 510(k) number is K871593.

When did TDXR FETAL LUNG MATURITY receive FDA 510(k) clearance?

TDXR FETAL LUNG MATURITY received FDA 510(k) clearance on 1987-07-20, under 510(k) number K871593.

Who is the listed applicant for TDXR FETAL LUNG MATURITY?

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

What is the FDA product code for TDXR FETAL LUNG MATURITY?

The FDA product code for TDXR FETAL LUNG MATURITY is JHG.

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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.K834616AMNIO STAT-FLM AGGLUTINATION TESTHana Biologics, Inc.K822150AMNISTAT-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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