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FDA 510(k)

PATHONORM H & L

K-Number: K771439 · 1977-09-02

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

Device Summary

PATHONORM H & L 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 K771439. 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 PATHONORM H & L?

PATHONORM H & L 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 K771439.

When did PATHONORM H & L receive FDA 510(k) clearance?

PATHONORM H & L received FDA 510(k) clearance on 1977-09-02, under 510(k) number K771439.

Who is the listed applicant for PATHONORM H & L?

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 PATHONORM H & L?

The FDA product code for PATHONORM H & L 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.

K771438AUTONORMK771437SERONORM LIPIDK771436SERONORM

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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