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FDA 510(k)

FETAL CHECK

K-Number: K792546 · 1979-12-18

ApplicantAlta Diagnostics, Inc.
Decision Date1979-12-18
Product CodeKJR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FETAL CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Alta Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-12-18 under 510(k) number K792546. The device is classified under product code KJR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETAL CHECK?

FETAL CHECK is a medical device that received FDA 510(k) clearance on 1979-12-18. The listed applicant is Alta Diagnostics, Inc.. The 510(k) number is K792546.

When did FETAL CHECK receive FDA 510(k) clearance?

FETAL CHECK received FDA 510(k) clearance on 1979-12-18, under 510(k) number K792546.

Who is the listed applicant for FETAL CHECK?

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

What is the FDA product code for FETAL CHECK?

The FDA product code for FETAL CHECK is KJR.

Related Clinical Trials

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Other records listing Alta Diagnostics, 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.

K800327MAGNESIUM REAGENTK792545URIC ACID KITK790797AMYLASE REAGENT SETK790796LIPASE REAGENT SET

Related Devices (Code: KJR)

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.

K842834HEP-2 CELLSBartels Immunodiagnostic Supplies, Inc.K842833PMK PRIMARY MONKEY KIDNEY-CELLSBartels Immunodiagnostic Supplies, Inc.

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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