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510(k) K851164

DENTOCULT CULTURE-PADDLE by Orion Corp. — Product Code JJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1985
Date Received
March 22, 1985
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 Orion Corp.

  • K912391 — RUBALEX, MODIFICATION (May 4, 1992)
  • K901637 — RESUBMITTED MODIFIED RUBALEX (April 26, 1990)
  • K884650 — RESUBMITTED SCANORA (March 16, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K881506 — MAMEX DC MAG MG12 (June 10, 1988)
  • K881505 — MAMEX DC MG11 (June 10, 1988)
  • K874040 — MAMEX DC S SL10/MG14 (November 23, 1987)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
  • K864457 — CHLAMYSET ANTIBODY EIA (September 11, 1987)
  • K872301 — DENTOCULT-SM CULTURE-PADDLE (September 11, 1987)

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)
  • K894902 — SOURCERER (October 17, 1989)
  • K884091 — SOURCERER (February 2, 1989)
  • K884269 — SAMPLE IDENTIFICATION STATION MODEL 38010 (January 9, 1989)
  • K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER (November 4, 1987)
  • K872429 — ISO-DATA 100 SERIES GAMMA COUNTER (August 21, 1987)