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510(k) K810268

NORMLCERA by Medical Specialties Laboratories — Product Code KIS

K810268 is an FDA 510(k) premarket notification submitted by Medical Specialties Laboratories for the device "NORMLCERA". The FDA issued a decision of Substantially Equivalent on March 6, 1981. The device falls under product code KIS (Sera, Animal And Human), a Class I device regulated under 21 CFR 864.2800. Medical Specialties Laboratories has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1981
Date Received
February 2, 1981
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 Medical Specialties Laboratories

  • K852643 — UNI-PLATE (August 8, 1985)
  • K844897 — HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 (March 22, 1985)
  • K840114 — COAGULATION FACTOR DEFICIENT PLASMA (February 4, 1984)
  • K823587 — UNI-CELL (January 5, 1983)

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)
  • K870467 — DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (March 24, 1987)
  • K870464 — CHARACTERIZED FETAL BOVINE SERUM #A-1115 (March 24, 1987)
  • K870463 — DEFINED FETAL BOVINE SERUM #A-1111 (March 24, 1987)
  • K870469 — DEFINED EQUINE SERUM #A-3311 (March 24, 1987)

FDA data resources