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510(k) K821659

RESPIRACULT-STREP DEEP BED CULTURE PAD by Orion Diagnostica, Inc. — Product Code JSH

K821659 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "RESPIRACULT-STREP DEEP BED CULTURE PAD". The FDA issued a decision of Substantially Equivalent on August 5, 1982. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1982
Date Received
June 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Orion Diagnostica, Inc.

  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K904655 — PYLORISET (October 21, 1991)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

Other clearances for product code JSH

  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources