Home / 510(k) Clearances / K871033

510(k) K871033

RABBIT KIDNEY CULTURE CELLS (FIRST PASS) by Microscan Div. Baxter Healthcare Corp. — Product Code KIR

K871033 is an FDA 510(k) premarket notification submitted by Microscan Div. Baxter Healthcare Corp. for the device "RABBIT KIDNEY CULTURE CELLS (FIRST PASS)". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Microscan Div. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1987
Date Received
March 16, 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 Microscan Div. Baxter Healthcare Corp.

  • K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (June 26, 1987)
  • K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (June 26, 1987)
  • K871233 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A (June 26, 1987)
  • K871231 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B (June 26, 1987)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K871230 — ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS (June 26, 1987)
  • K870814 — HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 (June 4, 1987)
  • K870074 — GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS (April 14, 1987)
  • K870089 — IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (March 17, 1987)

Other clearances for product code KIR

  • K973209 — FRESH CELLS VERO (September 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973211 — FRESH CELLS MV1LU (September 25, 1997)
  • K973214 — FRESH CELLS HFF (September 25, 1997)
  • K973212 — FRESH CELLS WI-38 (September 25, 1997)
  • K973213 — FRESH CELLS LLC-MK2 (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)
  • K962780 — FRESHCELLS, HEP-2 (August 29, 1996)

FDA data resources