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510(k) K905146

OLYMPUS URINE PH by Diagnostic Systems — Product Code JQY

K905146 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "OLYMPUS URINE PH". The FDA issued a decision of Substantially Equivalent on February 4, 1991. The device falls under product code JQY (Ph Meter), a Class I device regulated under 21 CFR 862.2050. Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1991
Date Received
November 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Meter
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Diagnostic Systems

  • K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411 (August 31, 1989)
  • K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (August 21, 1989)
  • K893966 — HDL PRECIPITATING REAGENT (July 25, 1989)
  • K884993 — VISUAL BLOOD GLUCOSE TEST SYSTEM (December 29, 1988)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (June 20, 1988)
  • K880787 — EASY-TEST LACTIC ACID (LA) (March 15, 1988)
  • K862403 — EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (July 11, 1986)
  • K854784 — ABSORBANCE (ABS) TEST PAK (December 19, 1985)
  • K853699 — EASY ANALYZER & EASY-TEST REAGENT (September 25, 1985)
  • K853533 — ABSORBANCE TEST SOLUTION (September 16, 1985)

Other clearances for product code JQY

  • K952178 — PH-DETECT TEST (October 20, 1995)
  • K872888 — CIBA CORNING 288 PH/BLOOD GAS SYSTEM (August 25, 1987)
  • K770347 — METER, PH, DIGITAL, MODEL 3560 (April 15, 1977)
  • K770352 — METER, IV PH, MODEL EXPANDOMATIC (April 8, 1977)
  • K770351 — METER, IV PH, MODEL ZEROMATIC (April 5, 1977)
  • K760789 — PH METER-130 (.001 PH) (November 16, 1976)
  • K760788 — PH METER-125 (.01 PH) (November 16, 1976)

FDA data resources