510(k) K943891

RD CULTURE CELL by Neogenex — Product Code KIR

K943891 is an FDA 510(k) premarket notification submitted by Neogenex for the device "RD CULTURE CELL". The FDA issued a decision of Substantially Equivalent on Nov 28, 1994. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Neogenex has 19 other 510(k) clearances on record.

Clearance details

Decision: SESE (Substantially Equivalent)
Decision Date: Nov 28, 1994
Date Received: Aug 9, 1994
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: 510(k) Exempt

Other clearances by Neogenex

K965047 — MINK LUNG CELL CULTURE (Feb 4, 1997)
K960909 — H292 CELL CULTURE (May 30, 1996)
K943884 — PRIMARY MONKEY KIDNEY CELL CULTURE (Nov 28, 1994)
K943888 — MDCK CELL CULTURE (Nov 28, 1994)
K943889 — VERO CELL CULTURE (Nov 28, 1994)
K943886 — BGM CELL CULTURE (Nov 28, 1994)
K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE (Nov 28, 1994)
K943887 — HUMAN NEWBORN FORESKIN CELL CULTURE (Nov 28, 1994)
K943890 — WI38 CELL CULTURE (Nov 28, 1994)
K941714 — CHLAMYDIA TRACHOMATIS ANTIGEN TEST (Jul 18, 1994)

Other clearances for product code KIR

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

510(k) K943891

Clearance details

Device classification

Other clearances by Neogenex

Other clearances for product code KIR

FDA data resources