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FDA 510(k)

DOSE CALIBRATION REF. SOURCES; BARIUM-13

K-Number: K800867 · 1980-05-28

ApplicantAmersham Corp.
Decision Date1980-05-28
Product Code
DecisionSubstantially Equivalent

Device Summary

DOSE CALIBRATION REF. SOURCES; BARIUM-13 is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800867. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOSE CALIBRATION REF. SOURCES; BARIUM-13?

DOSE CALIBRATION REF. SOURCES; BARIUM-13 is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Amersham Corp.. The 510(k) number is K800867.

When did DOSE CALIBRATION REF. SOURCES; BARIUM-13 receive FDA 510(k) clearance?

DOSE CALIBRATION REF. SOURCES; BARIUM-13 received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800867.

Who is the listed applicant for DOSE CALIBRATION REF. SOURCES; BARIUM-13?

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

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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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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.

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