Home / 510(k) Clearances / K833192

510(k) K833192

NORMAL URINE CONTROL by Biosan Laboratories, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1983
Date Received
September 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
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)
  • K834023 — BIO-SCIENCE LABORATORIES T4 REAGENT (January 24, 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)
  • K833319 — BIO-REX 70 RESIN 100-200 MESH PH6.2 (November 3, 1983)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)