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510(k) K022660

BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 by Biocheck, Inc. — Product Code DRR

K022660 is an FDA 510(k) premarket notification submitted by Biocheck, Inc. for the device "BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117". The FDA issued a decision of Substantially Equivalent on December 19, 2002. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Biocheck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2002
Date Received
August 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Biopotential
Device Class
Class II
Regulation Number
870.2050
Review Panel
CV
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)
  • 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)
  • K992528 — BIOCHECK IGE ELISA, MODEL BC-1035 (September 21, 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 DRR

  • K971570 — EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 (December 29, 1997)
  • K925346 — EP AMP, MODEL #901 (April 30, 1993)
  • K914381 — HORIZON 9000/HIS OPTION AMPLIFIER (January 28, 1992)
  • K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (July 22, 1991)
  • K910307 — CARDIOLAB AMPLIFIER MODULE (CAM) (April 12, 1991)
  • K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)
  • K894161 — ASC-950 ECG AMPLIFIER (August 3, 1989)
  • K874441 — BARD BIOPOTENTIAL AMPLIFIER (January 19, 1988)
  • K853652 — BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT (January 16, 1986)
  • K813123 — EPC FILTER (November 27, 1981)

FDA data resources