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510(k) K770351

METER, IV PH, MODEL ZEROMATIC by Beckman Instruments, Inc. — Product Code JQY

K770351 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "METER, IV PH, MODEL ZEROMATIC". The FDA issued a decision of Substantially Equivalent on April 5, 1977. The device falls under product code JQY (Ph Meter), a Class I device regulated under 21 CFR 862.2050. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1977
Date Received
February 22, 1977
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 Beckman Instruments, Inc.

  • K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, (September 17, 1998)
  • K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (July 14, 1998)
  • K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (May 8, 1998)
  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
  • K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (March 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (February 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (December 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (December 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (December 15, 1997)

Other clearances for product code JQY

  • K952178 — PH-DETECT TEST (October 20, 1995)
  • 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)
  • K760788 — PH METER-125 (.01 PH) (November 16, 1976)
  • K760789 — PH METER-130 (.001 PH) (November 16, 1976)

FDA data resources