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FDA 510(k)

CEDIA PHENYTOIN II ASSAY

K-Number: K963840 · 1996-11-20

ApplicantBoehringer Mannheim Corp.
Decision Date1996-11-20
Product CodeDIP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA PHENYTOIN II ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1996-11-20 under 510(k) number K963840. The device is classified under product code DIP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA PHENYTOIN II ASSAY?

CEDIA PHENYTOIN II ASSAY is a medical device that received FDA 510(k) clearance on 1996-11-20. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K963840.

When did CEDIA PHENYTOIN II ASSAY receive FDA 510(k) clearance?

CEDIA PHENYTOIN II ASSAY received FDA 510(k) clearance on 1996-11-20, under 510(k) number K963840.

Who is the listed applicant for CEDIA PHENYTOIN II ASSAY?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEDIA PHENYTOIN II ASSAY?

The FDA product code for CEDIA PHENYTOIN II ASSAY is DIP.

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Other records listing Boehringer Mannheim Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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Related Devices (Code: DIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K080696ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01Abbott LaboratoriesK063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSThermo Electron OYK030428ROCHE ONLINE TDM PHENYTOINRoche Diagnostics Corp.K011393RANDOX PHENYTOINRandox Laboratories, Ltd.K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229Syva Co.K000006IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6Diagnostic Products Corp.

Official Source

View on FDA Database →

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

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