Device Atlas

Bioscan Reagent Strips

Q: What is the product code of K943008?

The FDA product code is JJB – Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1115.

FDA 510(k) K943008 · Genesis Labs, Inc.

Substantially Equivalent

510(k) numberK943008

Submission

Device name: Bioscan Reagent Strips
Applicant: Genesis Labs, Inc.
Edina, MN, US
Received: June 24, 1994
Decision date: August 8, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JJB – Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Device class: Class I (low risk)
Regulation: 21 CFR 862.1115
Specialty: Clinical Chemistry

Other 510(k)s with product code JJB

510(k)	Device	Applicant	Decision
K943436	Urine Reagent STRIPS-8 ParametersJJB · Traditional	Teco Diagnostics	04/24/1995SE
K873553	Wako(Tm) Pretest 8AJJB · Traditional	Wako Chemicals USA, Inc.	09/22/1987SE
K862806	Urine Diagnostic Reagent StripsJJB · Traditional	Amatech International, Inc.	12/04/1986SE
K833521	Reagent Tests Strip CombinationsJJB · Traditional	Syn-Kit, Inc.	01/11/1984SE

More from Syn-Kit, Inc.

510(k)	Device	Decision
K961375	Dia Screen 10 Way Reagent StripsJIL · Traditional	06/18/1996SE
K952971	Dia Screen Reagent StripsJIL · Traditional	08/11/1995SE

Questions and answers

When was Bioscan Reagent Strips cleared by the FDA?

Bioscan Reagent Strips (K943008) received a 510(k) decision of Substantially Equivalent on August 8, 1994, 45 days after the submission was received.

What is the product code of K943008?

The FDA product code is JJB – Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1115.