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FDA 510(k)

HUMAN PROTEIN C RID TEST KIT

K-Number: K950015 · 1995-03-06

ApplicantJay H. Geller
Decision Date1995-03-06
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HUMAN PROTEIN C RID TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Jay H. Geller. It received FDA 510(k) clearance on 1995-03-06 under 510(k) number K950015. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMAN PROTEIN C RID TEST KIT?

HUMAN PROTEIN C RID TEST KIT is a medical device that received FDA 510(k) clearance on 1995-03-06. The listed applicant is Jay H. Geller. The 510(k) number is K950015.

When did HUMAN PROTEIN C RID TEST KIT receive FDA 510(k) clearance?

HUMAN PROTEIN C RID TEST KIT received FDA 510(k) clearance on 1995-03-06, under 510(k) number K950015.

Who is the listed applicant for HUMAN PROTEIN C RID TEST KIT?

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

What is the FDA product code for HUMAN PROTEIN C RID TEST KIT?

The FDA product code for HUMAN PROTEIN C RID TEST KIT is GGP.

Related Clinical Trials

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Other records listing Jay H. Geller 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.

K971658MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITK942326HUMAN C5 RID KITSK943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT

Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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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