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510(k) K790103

NEPHELOMETER, MIC-2000 LASER by Dynatech Corp. — Product Code JQX

K790103 is an FDA 510(k) premarket notification submitted by Dynatech Corp. for the device "NEPHELOMETER, MIC-2000 LASER". The FDA issued a decision of Substantially Equivalent on March 12, 1979. The device falls under product code JQX (Nephelometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2700. Dynatech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1979
Date Received
January 16, 1979
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 Dynatech Corp.

  • K904567 — DYNATECH MR4000 MICROPLATE READER (January 28, 1991)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)
  • K832117 — IMMULON SUBSTRATE REMOVAWELL STRIPS (August 8, 1983)
  • K823787 — HANDI-WASH (March 9, 1983)
  • K823833 — MICRO STIX #011-010-5000 & HOLDER#5100 (March 8, 1983)
  • K830200 — MICROELISA MINIREADER II (February 16, 1983)
  • K823773 — PROVIAL II #006-010-0201 (January 21, 1983)
  • K823557 — REMOVAWELL PLATE LID (December 28, 1982)

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)
  • K781554 — RAD-291 (October 11, 1978)
  • K781644 — ANTIBIOTIC NEPHELOMETER (October 3, 1978)

FDA data resources