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510(k) K800818

CHLAMYDOSPORE AGAR by Isle Media and Sterile Products, Inc. — Product Code JSH

K800818 is an FDA 510(k) premarket notification submitted by Isle Media and Sterile Products, Inc. for the device "CHLAMYDOSPORE AGAR". The FDA issued a decision of Substantially Equivalent on April 24, 1980. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Isle Media and Sterile Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1980
Date Received
April 11, 1980
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 Isle Media and Sterile Products, Inc.

  • K831671 — MODIFIED SOYBEAN CASEIN DIGEST BROTH (July 28, 1983)
  • K821218 — CAMPY-S AGAR (May 14, 1982)
  • K820863 — MEDIA FOR IN-VITRO DIAGNOSTIC USE (April 16, 1982)
  • K812795 — ANAEROBIC BLOOD AGAR (October 20, 1981)
  • K812797 — SCHAEDLER AGARS (October 20, 1981)
  • K812798 — MOTILITY GI MEDIUM (October 20, 1981)
  • K812796 — ANAEROBIC CNA BLOOD AGAR (October 20, 1981)
  • K800807 — CORN MEAL AGAR MEDIA (April 24, 1980)
  • K800333 — MODIFIED THAYER-MARTIN X AGAR (March 3, 1980)
  • K800334 — MARTIN-LEWIS AGAR (March 3, 1980)

Other clearances for product code JSH

  • K881540 — FLO AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K881551 — PHENOL RED BROTH BASE (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