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510(k) K772361

LASER IMMUNONEPHELOMETRIC ANALYZER by G.D. Searle and Co. — Product Code JQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1978
Date Received
December 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2700
Review Panel
CH
Submission Type

Other clearances by G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811068 — BYPASS COIL (May 27, 1981)
  • K811071 — VENOUS OXYGEN PROBE (May 5, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)

Other clearances for product code JQX

  • K962294 — IMMAGE IMMUNOCHEMISTRY SYSTEM (August 21, 1996)
  • K922273 — ARRAY(R) 360 (August 19, 1992)
  • K885263 — QMS(TM) - THEOPHYLLINE (March 28, 1989)
  • K851253 — TDX ANALYZER W/NEPHELOMETRY CAROUSEL (April 30, 1985)
  • K851234 — A-JUST TURBIDITY METER (April 29, 1985)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801089 — J.T. BAKER NEPHELOMETER (May 28, 1980)
  • K792045 — BIOVATION NEPHELOMETER (October 30, 1979)
  • K790103 — NEPHELOMETER, MIC-2000 LASER (March 12, 1979)
  • K781554 — RAD-291 (October 11, 1978)