FDA 510(k)

MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

K-Number: K011161 · 2001-05-15

Decision Date2001-05-15

Product CodeLCM

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co., Dade Behring, Inc.. It received FDA 510(k) clearance on 2001-05-15 under 510(k) number K011161. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229?

MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 is a medical device that received FDA 510(k) clearance on 2001-05-15. The listed applicant is Syva Co., Dade Behring, Inc.. The 510(k) number is K011161.

When did MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 receive FDA 510(k) clearance?

MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 received FDA 510(k) clearance on 2001-05-15, under 510(k) number K011161.

Who is the listed applicant for MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229?

The FDA 510(k) record lists Syva Co., Dade Behring, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229?

The FDA product code for MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 is LCM.

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Other records listing Syva Co., Dade Behring, Inc. as applicant

K011920EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 K011300EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 K011306EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 K011289EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229

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Related Devices (Code: LCM)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.