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510(k) K992528

BIOCHECK IGE ELISA, MODEL BC-1035 by Biocheck, Inc. — Product Code DGC

K992528 is an FDA 510(k) premarket notification submitted by Biocheck, Inc. for the device "BIOCHECK IGE ELISA, MODEL BC-1035". The FDA issued a decision of Substantially Equivalent on September 21, 1999. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Biocheck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1999
Date Received
July 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Biocheck, Inc.

  • K041619 — BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 (December 17, 2004)
  • K040030 — BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 (June 16, 2004)
  • K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (December 19, 2002)
  • K013062 — BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT (January 8, 2002)
  • K003851 — BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL (July 20, 2001)
  • K002294 — BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 (October 2, 2000)
  • K001022 — BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 (September 26, 2000)
  • K992517 — BIOCHECK FERRITIN ELISA MODEL BC-1025 (September 24, 1999)
  • K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 (July 22, 1999)
  • K991146 — TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 (June 22, 1999)

Other clearances for product code DGC

  • K231151 — Kenota 1 Total IgE; Kenota 1 (instrument) (May 31, 2024)
  • K214068 — Quantia IgE (February 21, 2023)
  • K220178 — Total Immunoglobulin E (IgE) (March 23, 2022)
  • K193493 — ADVIA Centaur Total IgE (tIgE) (January 15, 2020)
  • K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP To (July 28, 2016)
  • K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL L (February 24, 2014)
  • K063425 — DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONT (February 15, 2007)
  • K050493 — QUANTIA IGE (August 16, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K034057 — LACRYTEST (March 9, 2004)

FDA data resources