Api Uniscept KB

FDA 510(k) K843733 · Analytical Products, Inc.

Substantially Equivalent

510(k) numberK843733

Submission

Device name
Api Uniscept KB
Applicant
Analytical Products, Inc.
Mchenry, IL, US
Received
September 24, 1984
Decision date
October 24, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LTW – Susceptibility Test Cards, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Specialty
Microbiology

Other 510(k)s with product code LTW

510(k)DeviceApplicantDecision
K852613Mic-Concept SystemLTW · Traditional Microtech Medical Systems, Inc.09/20/1985SE
K853772Precept MethicillinLTW · Traditional Austin Biological Laboratories09/16/1985SE
K853685Precept TM CarbenicillinLTW · Traditional Austin Biological Laboratories09/16/1985SE
K853596Precept CefoperazoneLTW · Traditional Austin Biological Laboratories09/16/1985SE
K853273Precept CeftriaxoneLTW · Traditional Austin Biological Laboratories09/16/1985SE
K853689Precept TM MoxalactamLTW · Traditional Austin Biological Laboratories09/13/1985SE
K853688Precept TM TobramycinLTW · Traditional Austin Biological Laboratories09/13/1985SE
K853687Precept Netilmicin 32-13LTW · Traditional Austin Biological Laboratories09/13/1985SE
K853686Precept TM AmikacinLTW · Traditional Austin Biological Laboratories09/13/1985SE
K853684Precept KanamycinLTW · Traditional Austin Biological Laboratories09/13/1985SE

More from Austin Biological Laboratories

510(k)DeviceDecision
K924814Api 20E/UNISCEPT 20EJSS · Traditional 03/11/1993SE
K923684Api Uniscept Mic/Type 2 and 3 and Micro MicJWY · Traditional 12/03/1992SE
K922926Api Uniscept Kb/Type 2 and 3JWY · Traditional 10/13/1992SE
K901559Modification to Api Uniscept 20GPLQL · Traditional 09/10/1990SE
K901390Dmac Indole ReagentJTO · Traditional 04/16/1990SE
K895796Api Uniscept KBJWY · Traditional 11/13/1989SE
K884510Modification Micro-MicJWY · Traditional 11/22/1988SE
K884509Modification Mic/Api Uniscept(R)JWY · Traditional 11/22/1988SE
K880598Modifications to Api Uniscept (R) KBJWY · Traditional 03/23/1988SE
K874466Api Uniscept(R) Micro-Mic(R) System/Uniscept MicJWY · Traditional 12/09/1987SE

Questions and answers

When was Api Uniscept KB cleared by the FDA?

Api Uniscept KB (K843733) received a 510(k) decision of Substantially Equivalent on October 24, 1984, 30 days after the submission was received.

What is the product code of K843733?

The FDA product code is LTW – Susceptibility Test Cards, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.