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FDA 510(k)

PHENYTOIN RIA KIT

K-Number: K770779 · 1977-06-17

ApplicantAmersham Corp.
Decision Date1977-06-17
Product CodeDLP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENYTOIN RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1977-06-17 under 510(k) number K770779. The device is classified under product code DLP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHENYTOIN RIA KIT?

PHENYTOIN RIA KIT is a medical device that received FDA 510(k) clearance on 1977-06-17. The listed applicant is Amersham Corp.. The 510(k) number is K770779.

When did PHENYTOIN RIA KIT receive FDA 510(k) clearance?

PHENYTOIN RIA KIT received FDA 510(k) clearance on 1977-06-17, under 510(k) number K770779.

Who is the listed applicant for PHENYTOIN RIA KIT?

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

What is the FDA product code for PHENYTOIN RIA KIT?

The FDA product code for PHENYTOIN RIA KIT is DLP.

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Other records listing Amersham 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

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Related Devices (Code: DLP)

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.

K894527FPR PHENYTOIN KITColony Laboratories, Inc.K811775KALLESTAD ANTISERA TO PHENYTOINKallestad Laboratories, Inc.K792640FLUOROMATIC PHENYTOIN FIABio-RadK791896CENTRIA PHENYTOIN RIA TEST SETVentrex Laboratories, Inc.

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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