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510(k) K852396

HEK by Viromed Laboratories, Inc. — Product Code KIR

K852396 is an FDA 510(k) premarket notification submitted by Viromed Laboratories, Inc. for the device "HEK". The FDA issued a decision of Substantially Equivalent on July 12, 1985. 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
July 12, 1985
Date Received
June 6, 1985
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)
  • K871613 — BUFFALO GREEN MONKEY KIDNEY CELLS (May 13, 1987)
  • 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)
  • 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