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510(k) K843653

CAMPYLOCACTER SUPPLEMENT by Institute Virion , Ltd. — Product Code JSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1984
Date Received
September 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Institute Virion , Ltd.

  • K862814 — COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI (September 30, 1986)
  • K843657 — CYTOMEGALOVIRUS (September 26, 1985)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K843649 — ADENOVIRUS (September 26, 1985)
  • K843662 — MEASLES VIRUS RUBEOLA (September 26, 1985)
  • K843659 — INFLUENZA A2 VIRUS (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843660 — IN FLUENZA B VIRUS (September 26, 1985)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K843673 — RESPIRATORY SYNCYTIAL VIRUS (September 26, 1985)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881574 — W-L DIFFERENTIAL MEDIUM (April 18, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881549 — MYCOLOGICAL AGAR W/LOW PH (April 18, 1988)
  • K881570 — SABOURAUD MALTOSE AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)