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510(k) K861815

BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE by Hazleton Research Products, Inc. — Product Code KIS

K861815 is an FDA 510(k) premarket notification submitted by Hazleton Research Products, Inc. for the device "BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE". The FDA issued a decision of Substantially Equivalent on May 20, 1986. The device falls under product code KIS (Sera, Animal And Human), a Class I device regulated under 21 CFR 864.2800. Hazleton Research Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1986
Date Received
May 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sera, Animal And Human
Device Class
Class I
Regulation Number
864.2800
Review Panel
PA
Submission Type

Other clearances by Hazleton Research Products, Inc.

  • K861997 — PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (June 10, 1986)
  • K861996 — DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM (June 9, 1986)
  • K861871 — NCTC 109 MEDIUM (May 29, 1986)
  • K861869 — GENTAMICIN-50MG/ML (May 29, 1986)
  • K861873 — MEM GLASGOW MEDIUM (May 29, 1986)
  • K861874 — MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER (May 29, 1986)
  • K861887 — MEM GLASGOW POWDERED MEDIUM (May 29, 1986)
  • K861886 — DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM (May 29, 1986)
  • K861867 — MEM ALPHA EAGLE MEDIUM (May 29, 1986)
  • K861868 — WILLIAMS MEDIUM E (May 29, 1986)

Other clearances for product code KIS

  • K881287 — ANIMAL AND HUMAN SERA (April 5, 1988)
  • K880471 — BOVINE CALF SERUM SUPPLEMENTED #A-2159 (April 4, 1988)
  • K880470 — BOVINE CALF SERUM CATALOG #A-2119 (April 1, 1988)
  • K872847 — SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT (August 10, 1987)
  • K870580 — MLC NORMAL SERUM (April 8, 1987)
  • K870938 — FETAL BOVINE SERUM (March 31, 1987)
  • K870464 — CHARACTERIZED FETAL BOVINE SERUM #A-1115 (March 24, 1987)
  • K870463 — DEFINED FETAL BOVINE SERUM #A-1111 (March 24, 1987)
  • K870467 — DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (March 24, 1987)
  • K870469 — DEFINED EQUINE SERUM #A-3311 (March 24, 1987)

FDA data resources