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510(k) K861997

PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE by Hazleton Research Products, Inc. — Product Code JSK

K861997 is an FDA 510(k) premarket notification submitted by Hazleton Research Products, Inc. for the device "PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE". The FDA issued a decision of Substantially Equivalent on June 10, 1986. The device falls under product code JSK (Supplement, Culture Media), a Class I device regulated under 21 CFR 866.2450. Hazleton Research Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1986
Date Received
May 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Supplement, Culture Media
Device Class
Class I
Regulation Number
866.2450
Review Panel
MI
Submission Type

Other clearances by Hazleton Research Products, Inc.

  • K861996 — DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM (June 9, 1986)
  • K861868 — WILLIAMS MEDIUM E (May 29, 1986)
  • K861873 — MEM GLASGOW MEDIUM (May 29, 1986)
  • K861886 — DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM (May 29, 1986)
  • K861874 — MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER (May 29, 1986)
  • K861869 — GENTAMICIN-50MG/ML (May 29, 1986)
  • K861871 — NCTC 109 MEDIUM (May 29, 1986)
  • K861887 — MEM GLASGOW POWDERED MEDIUM (May 29, 1986)
  • K861867 — MEM ALPHA EAGLE MEDIUM (May 29, 1986)
  • K861870 — DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER (May 29, 1986)

Other clearances for product code JSK

  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (May 13, 1988)
  • K881566 — HEMOGLOBIN POWDER (April 18, 1988)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K855172 — KWI (TM) G-CO/TWO (February 20, 1986)
  • K853546 — ABBOTT CATION SUPPLEMENT SOLUTION (September 6, 1985)
  • K850302 — SUPLEX & SUPLEX DILUENT (March 22, 1985)
  • K850300 — MUCOLYSE (March 20, 1985)

FDA data resources