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FDA 510(k)

ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH

K-Number: K770606 · 1977-05-06

ApplicantDamon Corp.
Decision Date1977-05-06
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Damon Corp.. It received FDA 510(k) clearance on 1977-05-06 under 510(k) number K770606. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH?

ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH is a medical device that received FDA 510(k) clearance on 1977-05-06. The listed applicant is Damon Corp.. The 510(k) number is K770606.

When did ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH receive FDA 510(k) clearance?

ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH received FDA 510(k) clearance on 1977-05-06, under 510(k) number K770606.

Who is the listed applicant for ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH?

The FDA 510(k) record lists Damon Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH?

The FDA product code for ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH is JPA.

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Other records listing Damon Corp. 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.

K874865DAMON D.E.T.E.C.T IMAGE ENHANCERK831826ADRENOCORTICOTROPIN RADIO-IMMUNOASSAYK820686LIQUISOL PROGESTERONE RADIOIMMUNOK802661LIQUISOL TESTOSTERONE RADIOIMM. TEST KITK790250LIQUISOL CORTISOL RIA TEST KITK782124IEC CENTRA-7 CENTRIFUGE MODEL 2362

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Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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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