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510(k) K861814

RHESUS MONKEY SERUM - STERILE FILTERED by Hazleton Research Products, Inc. — Product Code KIS

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)
  • K861872 — ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM (May 29, 1986)
  • K861887 — MEM GLASGOW POWDERED MEDIUM (May 29, 1986)
  • K861875 — RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER (May 29, 1986)
  • K861868 — WILLIAMS MEDIUM E (May 29, 1986)
  • K861873 — MEM GLASGOW MEDIUM (May 29, 1986)
  • K861885 — WILLIAMS MEDIUM E POWDER (May 29, 1986)
  • K861870 — DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER (May 29, 1986)
  • K861886 — DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM (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)
  • 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)
  • K870465 — 6/40 FETAL BOVINE SERUM #A-1110 (March 24, 1987)