Applied Laboratories, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1831301
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
What Applied Laboratories, Inc. makes
Applied Laboratories, Inc. manufactures sterile saline solutions for ophthalmic use, as well as contact lens carrying cases, including branded options like the Easy Eyes™ and Kestrel models. The company also produces colored and uncolored plastic components, such as GE Lexan 144R 112, Noryl 731-80089S, and various Makrolon and Merlon grades from Mobay (Bayer), used in medical device applications.
The portfolio includes devices classified as Class II and unclassified (Class U) under FDA regulations, with some products authorised via the 510(k) and PMA pathways. These items are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
Ge Lexan 144R 112 Ref K873825
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Mobay (Bayer) Makrolon 2658 1112 Ref K873820
Regimes: 510(k) Registry: 510(k)Easy Eyes Tm Lens Carrying Case Ref K853870
Regimes: 510(k) Registry: 510(k)Mobay (Bayer) Merlon M-40 (H)F 1112 Ref K873822
Regimes: 510(k) Registry: 510(k)Easy Eyes Tm Lens Carrying Case Ref K860677
Regimes: 510(k) Registry: 510(k)Ge Noryl 731-80089S Ref K873821
Regimes: 510(k) Registry: 510(k)Kestrel Contact Lens Case Ref K871714
Regimes: 510(k) Registry: 510(k)Mobay (Bayer) Makrolon 2658 3291 Ref K873823
Regimes: 510(k) Registry: 510(k)Applied Laboratories Sterile Saline Solution Ref P870002
Regimes: PMA Registry: PMA
Company details
- FDA FEI number
- 1831301
- Address
- 3240 N. Indianapolis Rd., COLUMBUS, IN, 47201
Frequently asked questions
How many devices does APPLIED LABORATORIES, INC. have in the registry?
The registry currently lists 10 devices for APPLIED LABORATORIES, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list APPLIED LABORATORIES, INC.'s devices?
Among its 10 most recently registered devices, APPLIED LABORATORIES, INC. has devices listed in FDA 510(k) (9 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do APPLIED LABORATORIES, INC.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for APPLIED LABORATORIES, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from APPLIED LABORATORIES, INC. in the registry?
The most recently registered devices listed for APPLIED LABORATORIES, INC. include GE LEXAN 144R 112, RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000, MOBAY (BAYER) MAKROLON 2658 1112 and EASY EYES TM LENS CARRYING CASE.