Home / 510(k) Clearances / K952178

510(k) K952178

PH-DETECT TEST by Diagnostic Reagents, Inc. — Product Code JQY

K952178 is an FDA 510(k) premarket notification submitted by Diagnostic Reagents, Inc. for the device "PH-DETECT TEST". The FDA issued a decision of Substantially Equivalent on October 20, 1995. The device falls under product code JQY (Ph Meter), a Class I device regulated under 21 CFR 862.2050. Diagnostic Reagents, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1995
Date Received
May 9, 1995
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 Reagents, Inc.

  • K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (November 18, 1998)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • K983323 — DIGOXIN IMMUNOASSAY (November 12, 1998)
  • K983280 — VANCOMYCIN EIA ASSAY (November 6, 1998)
  • K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (November 5, 1998)
  • K973102 — LIDOCAINE EIA ASSAY (September 12, 1997)
  • K972835 — 50NG/ML COCAINE METABOLITE CALIBRATOR (August 28, 1997)
  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K963835 — DIGOXIN ENZYME IMMUNOASSAY (December 10, 1996)

Other clearances for product code JQY

  • K905146 — OLYMPUS URINE PH (February 4, 1991)
  • 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