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510(k) K894902

SOURCERER by Oakfield Instruments, Ltd. — Product Code JJJ

K894902 is an FDA 510(k) premarket notification submitted by Oakfield Instruments, Ltd. for the device "SOURCERER". The FDA issued a decision of Substantially Equivalent on October 17, 1989. The device falls under product code JJJ (Counter (Beta, Gamma) For Clinical Use), a Class I device regulated under 21 CFR 862.2320. Oakfield Instruments, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1989
Date Received
August 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter (Beta, Gamma) For Clinical Use
Device Class
Class I
Regulation Number
862.2320
Review Panel
CH
Submission Type

Other clearances by Oakfield Instruments, Ltd.

  • K964804 — FLEXILOG LS (August 6, 1997)
  • K964589 — FLEXILOG 3000 (March 4, 1997)
  • K961895 — FLEXILOG LS 13921 (November 4, 1996)
  • K945069 — FLEXILOG 2000 (June 13, 1995)
  • K920115 — MEDISCINT (March 30, 1992)
  • K902460 — CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) (August 28, 1990)
  • K896288 — FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM (May 4, 1990)

Other clearances for product code JJJ

  • K962762 — SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (August 16, 1996)
  • K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (March 30, 1995)
  • K920559 — ABBOTT VERTEX ANALYZER (March 19, 1992)
  • K900087 — GENESYS 6000 GAMMA COUNTER (July 19, 1990)
  • K896202 — MATRIX(TM)-96 (January 2, 1990)
  • K884091 — SOURCERER (February 2, 1989)
  • K884269 — SAMPLE IDENTIFICATION STATION MODEL 38010 (January 9, 1989)
  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872430 — ISO-DATA 500 SERIES GAMMA COUNTER (August 21, 1987)
  • K872429 — ISO-DATA 100 SERIES GAMMA COUNTER (August 21, 1987)

FDA data resources