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510(k) K930689

AUTOBEAD THYROID UPTAKE by Bio-Chem Laboratory Systems, Inc. — Product Code KHO

K930689 is an FDA 510(k) premarket notification submitted by Bio-Chem Laboratory Systems, Inc. for the device "AUTOBEAD THYROID UPTAKE". The FDA issued a decision of Substantially Equivalent on November 10, 1993. The device falls under product code KHO (Fluorometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2560. Bio-Chem Laboratory Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1993
Date Received
February 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type

Other clearances by Bio-Chem Laboratory Systems, Inc.

  • K945271 — ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM (April 20, 1995)
  • K930006 — AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (September 9, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K924084 — ATAC 6000 CHEMISTRY ANALYZER (September 29, 1992)

Other clearances for product code KHO

  • K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, (January 20, 2012)
  • K973547 — TRIAGE STATMETER (January 13, 1998)
  • K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (June 27, 1997)
  • K962919 — VITROS IMMUNODIAGNOSTIC SYSTEM (October 18, 1996)
  • K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (November 22, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K935047 — AUTO DELFIA (May 23, 1994)
  • K926131 — OPUS MAGNUM ANALYZER (June 7, 1993)
  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
  • K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (March 19, 1992)

FDA data resources