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FDA 510(k)

CONTROL SERA LEVEL VALUES (MG/DL)

K-Number: K861567 · 1986-05-23

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1986-05-23
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONTROL SERA LEVEL VALUES (MG/DL) is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1986-05-23 under 510(k) number K861567. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROL SERA LEVEL VALUES (MG/DL)?

CONTROL SERA LEVEL VALUES (MG/DL) is a medical device that received FDA 510(k) clearance on 1986-05-23. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K861567.

When did CONTROL SERA LEVEL VALUES (MG/DL) receive FDA 510(k) clearance?

CONTROL SERA LEVEL VALUES (MG/DL) received FDA 510(k) clearance on 1986-05-23, under 510(k) number K861567.

Who is the listed applicant for CONTROL SERA LEVEL VALUES (MG/DL)?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTROL SERA LEVEL VALUES (MG/DL)?

The FDA product code for CONTROL SERA LEVEL VALUES (MG/DL) is JJY.

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Related Devices (Code: JJY)

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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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