FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

FDL, INC.'S TRANSPORT SYSTEM

K Number: K895187 · Decision Oct 24, 1989
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
42
Applicant Total
7
Review Days
74

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
FDL, INC.'S TRANSPORT SYSTEM
K Number
K895187
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
866.2900
Medical Specialty
Microbiology
Decision
Substantially Equivalent
Applicant
Fairleigh Dickinson Laboratories, Inc.
Date Received
August 11, 1989
Decision Date
October 24, 1989
Product Code
JTW
Advisory Committee
Microbiology
Review Advisory Committee
MI
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JTW System, Transport, Aerobic

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (JTW), ordered by most recent decision date.

View all

Other Clearances by Fairleigh Dickinson Laboratories, Inc.

K Number Device Name
K896032 MODIFIED ELISA FOR CHLAMYDIA
K883266 FDL ELISA FOR CHLAMYDIA
K881502 BREWER GEL FOR CAMPYLOBACTER
K875362 BREWER GEL FOR ANAEROBES
K853307 DIRECT ELISA FOR HERPES SIMPLEX VIRUS
K850251 ROTALOK SURGICAL HAND TABLE