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FDA 510(k)

IMMUNOSPOT NEONATAL T4 TEST

K-Number: K771606 · 1977-09-15

ApplicantMeloy Laboratories, Inc.
Decision Date1977-09-15
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNOSPOT NEONATAL T4 TEST is the device name listed in this FDA 510(k) record. The listed applicant is Meloy Laboratories, Inc.. It received FDA 510(k) clearance on 1977-09-15 under 510(k) number K771606. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOSPOT NEONATAL T4 TEST?

IMMUNOSPOT NEONATAL T4 TEST is a medical device that received FDA 510(k) clearance on 1977-09-15. The listed applicant is Meloy Laboratories, Inc.. The 510(k) number is K771606.

When did IMMUNOSPOT NEONATAL T4 TEST receive FDA 510(k) clearance?

IMMUNOSPOT NEONATAL T4 TEST received FDA 510(k) clearance on 1977-09-15, under 510(k) number K771606.

Who is the listed applicant for IMMUNOSPOT NEONATAL T4 TEST?

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

What is the FDA product code for IMMUNOSPOT NEONATAL T4 TEST?

The FDA product code for IMMUNOSPOT NEONATAL T4 TEST is CDX.

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Other records listing Meloy Laboratories, 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.

K852033SS-A(RO) & SS-B(LA) ANTIBODY ASSAYK844678MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CULK841708MELOY IMMUNOSTAT MONOCLONAL FACTOR VIIIK842247MELOY AUTOANTIBODY TEST SYSK831292ANTI-ENA TESTK820265ANA TEST (MOUSE LIVER SUBSTRATE)

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Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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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