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510(k) K821175

GASTRIN RADIOIMMUNOASSAY KIT (125-I) by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code CGC

K821175 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "GASTRIN RADIOIMMUNOASSAY KIT (125-I)". The FDA issued a decision of Substantially Equivalent on May 14, 1982. The device falls under product code CGC (Radioimmunoassay, Gastrin), a Class I device regulated under 21 CFR 862.1325. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1982
Date Received
April 26, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Gastrin
Device Class
Class I
Regulation Number
862.1325
Review Panel
CH
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (March 21, 2001)
  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code CGC

  • K961276 — GASTRIN EIA MODEL 06B-555017 (May 30, 1996)
  • K842079 — GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY (June 26, 1984)
  • K841963 — GASTRIN RIA (June 25, 1984)
  • K833489 — DPC GASTRIN KIT (January 30, 1984)
  • K831075 — BLOOD GAS & FLAME PHOTOMETER INSTRU- (June 22, 1983)
  • K812727 — GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT (November 5, 1981)
  • K812004 — GASTRIN RIA DIAGNOSTIC KIT (July 28, 1981)
  • K810722 — GASTRIN RADIOIMMUNOASSAY TEST (May 27, 1981)
  • K771953 — GASTRIN RIA MODULE (January 20, 1978)

FDA data resources