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FDA 510(k)

ANALYZER, SERUM IRON & TOTAL IRON BINDIN

K-Number: K781009 · 1978-07-27

ApplicantEnvironmental Sciences Assoc., Inc.
Decision Date1978-07-27
Product CodeJMD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYZER, SERUM IRON & TOTAL IRON BINDIN is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Sciences Assoc., Inc.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K781009. The device is classified under product code JMD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANALYZER, SERUM IRON & TOTAL IRON BINDIN?

ANALYZER, SERUM IRON & TOTAL IRON BINDIN is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Environmental Sciences Assoc., Inc.. The 510(k) number is K781009.

When did ANALYZER, SERUM IRON & TOTAL IRON BINDIN receive FDA 510(k) clearance?

ANALYZER, SERUM IRON & TOTAL IRON BINDIN received FDA 510(k) clearance on 1978-07-27, under 510(k) number K781009.

Who is the listed applicant for ANALYZER, SERUM IRON & TOTAL IRON BINDIN?

The FDA 510(k) record lists Environmental Sciences Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANALYZER, SERUM IRON & TOTAL IRON BINDIN?

The FDA product code for ANALYZER, SERUM IRON & TOTAL IRON BINDIN is JMD.

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Other records listing Environmental Sciences Assoc., Inc. 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.

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Related Devices (Code: JMD)

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.

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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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