Home / 510(k) Clearances / K781390

510(k) K781390

MYCOPLASMA HYORHINIS (BTS-7) by Flow Laboratories, Inc. — Product Code KPB

K781390 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "MYCOPLASMA HYORHINIS (BTS-7)". The FDA issued a decision of Substantially Equivalent on September 1, 1978. The device falls under product code KPB (Media And Components, Mycoplasma Detection), a Class I device regulated under 21 CFR 864.2360. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1978
Date Received
August 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Mycoplasma Detection
Device Class
Class I
Regulation Number
864.2360
Review Panel
PA
Submission Type

Other clearances by Flow Laboratories, Inc.

  • K861897 — UNISKAN II (July 1, 1986)
  • K862066 — TITERTEK MICROPLATE WASHER S-12 (June 5, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K860752 — GOAT SERUM (29-391-54) (March 10, 1986)
  • K860762 — GAMMA-FREE HORSE SERUM (March 10, 1986)
  • K850908 — TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (March 25, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)

Other clearances for product code KPB

  • K781875 — STAIN KIT FOR CELL CULTURES (30-100-00) (December 20, 1978)
  • K781874 — MYCOPLASMA ARGININI FITC (30-403-41) (December 20, 1978)
  • K771867 — MYCOPLASMA DETECTION KIT (November 17, 1977)

FDA data resources