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510(k) K854784

ABSORBANCE (ABS) TEST PAK by Diagnostic Systems — Product Code JIT

K854784 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "ABSORBANCE (ABS) TEST PAK". The FDA issued a decision of Substantially Equivalent on Dec 19, 1985. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 19, 1985
Date Received
Nov 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Diagnostic Systems

  • K905146 — OLYMPUS URINE PH (Feb 4, 1991)
  • K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411 (Aug 31, 1989)
  • K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (Aug 21, 1989)
  • K893966 — HDL PRECIPITATING REAGENT (Jul 25, 1989)
  • K884993 — VISUAL BLOOD GLUCOSE TEST SYSTEM (Dec 29, 1988)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (Jun 20, 1988)
  • K880787 — EASY-TEST LACTIC ACID (LA) (Mar 15, 1988)
  • K862403 — EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (Jul 11, 1986)
  • K853699 — EASY ANALYZER & EASY-TEST REAGENT (Sep 25, 1985)
  • K853533 — ABSORBANCE TEST SOLUTION (Sep 16, 1985)

Other clearances for product code JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (Apr 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (Feb 15, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (Jan 13, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (Jan 13, 2017)
  • K163544 — Lumipulse G Prolactin (Jan 12, 2017)
  • K163521 — Lumipulse G LH Calibrators (Jan 12, 2017)
  • K163078 — DC-UIBC-CAL (Dec 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (Dec 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (Nov 17, 2016)

FDA data resources