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FDA 510(k)

VIRGO(R) MICROWELL ALT ASSAY

K-Number: K884784 · 1988-12-29

ApplicantElectro-Nucleonics, Inc.
Decision Date1988-12-29
Product CodeCKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIRGO(R) MICROWELL ALT ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics, Inc.. It received FDA 510(k) clearance on 1988-12-29 under 510(k) number K884784. The device is classified under product code CKD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRGO(R) MICROWELL ALT ASSAY?

VIRGO(R) MICROWELL ALT ASSAY is a medical device that received FDA 510(k) clearance on 1988-12-29. The listed applicant is Electro-Nucleonics, Inc.. The 510(k) number is K884784.

When did VIRGO(R) MICROWELL ALT ASSAY receive FDA 510(k) clearance?

VIRGO(R) MICROWELL ALT ASSAY received FDA 510(k) clearance on 1988-12-29, under 510(k) number K884784.

Who is the listed applicant for VIRGO(R) MICROWELL ALT ASSAY?

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

What is the FDA product code for VIRGO(R) MICROWELL ALT ASSAY?

The FDA product code for VIRGO(R) MICROWELL ALT ASSAY is CKD.

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Other records listing Electro-Nucleonics, 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.

K893718DELTATEST (R) LIPASE IIK883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIK883427VIRGO(R) VZV-IGG ELISAK883282VIRGO HSV-1 IGG ELISAK883281VIRGO HSV-2 IGG ELISAK883102VIRGO (R) CMV-IGG ELISA

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Related Devices (Code: CKD)

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.

K991834CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772Cholestech Corp.K941192ORTHO ALT MICROWELL TEST SYSTEMOrtho Diagnostic Systems, Inc.K896237COBAS READY ALT REAGENTRoche Diagnostic Systems, Inc.K883387ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)Tech-Co, Inc.K864082REFLOTRON(R) ALT (GPT)Boehringer Mannheim Corp.K860485SGPT (ALT) REAGENT SET (COLORIMETRIC)Sterling 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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