Name: Predicase
Price: 199 USD

K-number	K943780
Device name	NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
Applicant	Heraeus Kulzer, Inc.
Product code	JJW
Device class	Class I
Decision date	Oct 31, 1994
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)

Everything you need for a 510(k) submission. Nothing you don't.