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510(k) K781554

RAD-291 by Organon, Inc. — Product Code JQX

K781554 is an FDA 510(k) premarket notification submitted by Organon, Inc. for the device "RAD-291". The FDA issued a decision of Substantially Equivalent on October 11, 1978. The device falls under product code JQX (Nephelometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2700. Organon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1978
Date Received
September 11, 1978
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 Organon, Inc.

  • K253642 — Jada System (Jada-2002) (May 15, 2026)
  • K950861 — RECONSTITUTION ACCESSOREIS (May 26, 1995)
  • K853388 — MONOSTICON UNI-DOT (August 22, 1985)
  • K842314 — DUOCLON COLOR-CEPT (August 24, 1984)
  • K841525 — OREIA II B-HCG PREGNANCY TEST KIT (June 5, 1984)
  • K841602 — ACCURATE BETA 30 PREGNANCY TEST KIT (May 22, 1984)
  • K840650 — B-NEOCEPT 30 (April 4, 1984)
  • K832801 — OREIA II B-HCG, ENZYME INNUNOASSAY (December 8, 1983)
  • K831339 — NEO-PREGNOSTICON DUOCLON TUBE TEST (June 8, 1983)
  • K831109 — DUOCLON SLIDE TEST (June 2, 1983)

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)
  • K781644 — ANTIBIOTIC NEPHELOMETER (October 3, 1978)

FDA data resources