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510(k) K770004

P.R.A.S. CARY & BLAIR TRANSPORT MEDIUM by Scott Laboratories, Inc. — Product Code JSJ

K770004 is an FDA 510(k) premarket notification submitted by Scott Laboratories, Inc. for the device "P.R.A.S. CARY & BLAIR TRANSPORT MEDIUM". The FDA issued a decision of Substantially Equivalent on January 14, 1977. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Scott Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1977
Date Received
January 3, 1977
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 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 JSJ

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

FDA data resources