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FDA 510(k)

SERONORM

K-Number: K771436 · 1977-09-02

ApplicantNyegaard & Co. A/S
Decision Date1977-09-02
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERONORM is the device name listed in this FDA 510(k) record. The listed applicant is Nyegaard & Co. A/S. It received FDA 510(k) clearance on 1977-09-02 under 510(k) number K771436. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERONORM?

SERONORM is a medical device that received FDA 510(k) clearance on 1977-09-02. The listed applicant is Nyegaard & Co. A/S. The 510(k) number is K771436.

When did SERONORM receive FDA 510(k) clearance?

SERONORM received FDA 510(k) clearance on 1977-09-02, under 510(k) number K771436.

Who is the listed applicant for SERONORM?

The FDA 510(k) record lists Nyegaard & Co. A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERONORM?

The FDA product code for SERONORM is JJT.

Related Clinical Trials

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.

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Other records listing Nyegaard & Co. A/S 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.

K771439PATHONORM H & LK771438AUTONORMK771437SERONORM LIPID

Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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