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510(k) K843653

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

K843653 is an FDA 510(k) premarket notification submitted by Institute Virion , Ltd. for the device "CAMPYLOCACTER SUPPLEMENT". The FDA issued a decision of Substantially Equivalent on October 23, 1984. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Institute Virion , Ltd. has at least 10 other 510(k) clearances on record.

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)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K843673 — RESPIRATORY SYNCYTIAL VIRUS (September 26, 1985)
  • K843658 — H. SIMPLEX VIRUS (September 26, 1985)
  • K843659 — INFLUENZA A2 VIRUS (September 26, 1985)
  • K843657 — CYTOMEGALOVIRUS (September 26, 1985)
  • K843660 — IN FLUENZA B VIRUS (September 26, 1985)
  • K843649 — ADENOVIRUS (September 26, 1985)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources