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510(k) K761019

PIPETTER-DILUTER (MODEL 273) by Beckman Instruments, Inc. — Product Code JRW

K761019 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "PIPETTER-DILUTER (MODEL 273)". The FDA issued a decision of Substantially Equivalent on November 16, 1976. The device falls under product code JRW (Antisera, Fluorescent, B. Parapertussis), a Class I device regulated under 21 CFR 866.3065. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1976
Date Received
November 11, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, B. Parapertussis
Device Class
Class I
Regulation Number
866.3065
Review Panel
MI
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 JRW

  • K780713 — CULTURE SWAB (May 12, 1978)

FDA data resources