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510(k) K771936

MICROBIOLOGICAL CULTURE MEDIUM by Scott Laboratories, Inc. — Product Code JSH

K771936 is an FDA 510(k) premarket notification submitted by Scott Laboratories, Inc. for the device "MICROBIOLOGICAL CULTURE MEDIUM". The FDA issued a decision of Substantially Equivalent on December 6, 1977. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Scott Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1977
Date Received
October 17, 1977
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 Scott Laboratories, Inc.

  • K880694 — B. CAT CONFIRM (June 16, 1988)
  • K874933 — MUG-INDOLE DISC (January 5, 1988)
  • K874662 — MYCO-FLUOR REAGENT A & B (November 25, 1987)
  • K873509 — IDENTICULT-BL (October 15, 1987)
  • K871238 — ANABAG (April 3, 1987)
  • K863025 — SERO-STAT R II STAPHYLOCOCCUS TEST (September 15, 1986)
  • K852869 — SELECTICULT-CHLAMYDIA (September 19, 1985)
  • K852832 — IDENTICULT-NEISSERIA (July 19, 1985)
  • K852666 — IDENTICULT-AE (July 15, 1985)
  • K841680 — SCOTT SELECTICULT-HSV ISOLATION & (October 30, 1984)

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