HUMAN PROTEIN C RID TEST KIT— 510(k) K950015

Substantially Equivalent

Jay H. Geller

FDA 510(k) clearance K950015 for HUMAN PROTEIN C RID TEST KIT, Substantially Equivalent on 1995-03-06. Applicant: Jay H. Geller. Device class: 2.

Clearance details

Applicant: Jay H. Geller
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1995-01-03
Decision date: 1995-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGP

K251440 — CRYOcheck Chromogenic Factor VIII2025-08-25
K230852 — HemosIL Chromogenic Factor IX2023-12-13
K220728 — vWF Ag2023-06-02
K214002 — CRYOcheck Chromogenic Factor IX2022-12-23
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09

More clearances from Jay H. Geller

K971658 — MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT1997-05-23
K942326 — HUMAN C5 RID KITS1995-08-24
K943334 — HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT1994-10-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.