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510(k) K871613

BUFFALO GREEN MONKEY KIDNEY CELLS by Viromed Laboratories, Inc. — Product Code KIR

K871613 is an FDA 510(k) premarket notification submitted by Viromed Laboratories, Inc. for the device "BUFFALO GREEN MONKEY KIDNEY CELLS". The FDA issued a decision of Substantially Equivalent on May 13, 1987. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Viromed Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1987
Date Received
April 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cells, Animal And Human, Cultured
Device Class
Class I
Regulation Number
864.2280
Review Panel
PA
Submission Type

Other clearances by Viromed Laboratories, Inc.

  • K951440 — LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE (May 22, 1996)
  • K951461 — NCI-H292 CELL CULTURE (May 22, 1996)
  • K862555 — HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) (July 10, 1986)
  • K861373 — HUMAN LUNG CARCINOMA CELLS (A549) (April 18, 1986)
  • K853695 — RESPIRATORY SYNCYTIAL VIRUS ID REAGENT (December 4, 1985)
  • K852396 — HEK (July 12, 1985)
  • K852395 — MINK LUNG (July 12, 1985)
  • K852394 — MDCK (July 12, 1985)
  • K843252 — AFRICAN GREEN SV 5/SV 40 (September 6, 1984)
  • K843250 — BHK-21 (September 6, 1984)

Other clearances for product code KIR

  • K973214 — FRESH CELLS HFF (September 25, 1997)
  • K973209 — FRESH CELLS VERO (September 25, 1997)
  • K973213 — FRESH CELLS LLC-MK2 (September 25, 1997)
  • K973211 — FRESH CELLS MV1LU (September 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973212 — FRESH CELLS WI-38 (September 25, 1997)
  • K971508 — RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (September 17, 1997)
  • K972414 — FRESHCELLS (August 29, 1997)
  • K965047 — MINK LUNG CELL CULTURE (February 4, 1997)
  • K962782 — FRESHFROZEN CELLS, HEP-2 (August 29, 1996)

FDA data resources