Home / 510(k) Clearances / K885263

510(k) K885263

QMS(TM) - THEOPHYLLINE by Seradyn, Inc. — Product Code JQX

K885263 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "QMS(TM) - THEOPHYLLINE". The FDA issued a decision of Substantially Equivalent on March 28, 1989. The device falls under product code JQX (Nephelometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2700. Seradyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1989
Date Received
December 23, 1988
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 Seradyn, Inc.

  • K070645 — SERADYN QMS TOPIRAMATE (May 17, 2007)
  • K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (January 12, 2007)
  • K062204 — ARCHITECT CORTISOL ASSAY (September 22, 2006)
  • K060998 — QMS TOBRAMYCIN (July 21, 2006)
  • K060709 — MULTIGENT GENTAMICIN (June 15, 2006)
  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (November 18, 2005)
  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K050419 — QMS VANCOMYCIN (April 1, 2005)
  • K042307 — ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (November 3, 2004)

Other clearances for product code JQX

  • K962294 — IMMAGE IMMUNOCHEMISTRY SYSTEM (August 21, 1996)
  • K922273 — ARRAY(R) 360 (August 19, 1992)
  • 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)
  • K781644 — ANTIBIOTIC NEPHELOMETER (October 3, 1978)

FDA data resources