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510(k) K834023

BIO-SCIENCE LABORATORIES T4 REAGENT by Biosan Laboratories, Inc. — Product Code CDX

K834023 is an FDA 510(k) premarket notification submitted by Biosan Laboratories, Inc. for the device "BIO-SCIENCE LABORATORIES T4 REAGENT". The FDA issued a decision of Substantially Equivalent on January 24, 1984. The device falls under product code CDX (Radioimmunoassay, Total Thyroxine), a Class II device regulated under 21 CFR 862.1700. Biosan Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1984
Date Received
November 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

Other clearances by Biosan Laboratories, Inc.

  • K860642 — PHOTRON VISUAL FIELD ANALYZER (April 15, 1986)
  • K853812 — PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (November 1, 1985)
  • K832763 — TOBRAMYCIN REAGENT (March 23, 1984)
  • K833193 — RADIOIMMUNOASSAY, THYROID STIMU. HORMONE (February 4, 1984)
  • K833318 — NORMAL GOAT SERUM (January 3, 1984)
  • K833320 — AMBERLITE CG50 RESIN, 100-200 MESH (December 8, 1983)
  • K833191 — ABNORMAL URINE CONTROL (December 8, 1983)
  • K833192 — NORMAL URINE CONTROL (December 8, 1983)
  • K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2 (November 3, 1983)

Other clearances for product code CDX

  • K961490 — ELECSYS T4 ASSAY (June 13, 1996)
  • K954312 — ACTIVE THYROXINE RIA (October 7, 1995)
  • K943416 — DELFIA NEONATAL THYROXINE KIT (March 10, 1995)
  • K934384 — AXSYM(TM) TOTAL T4 (June 21, 1994)
  • K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (October 18, 1993)
  • K933426 — STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (August 26, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K925110 — ABBOTT IMX T4 (January 26, 1993)
  • K925109 — ABBOTT TDX/TDXFLX TT4 (January 4, 1993)

FDA data resources