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FDA 510(k)

REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL

K-Number: K873105 · 1987-09-16

ApplicantStreck Laboratories, Inc.
Decision Date1987-09-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 1987-09-16 under 510(k) number K873105. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL?

REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL is a medical device that received FDA 510(k) clearance on 1987-09-16. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K873105.

When did REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL receive FDA 510(k) clearance?

REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL received FDA 510(k) clearance on 1987-09-16, under 510(k) number K873105.

Who is the listed applicant for REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL?

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

What is the FDA product code for REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL?

The FDA product code for REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL is JJX.

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Other records listing Streck Laboratories, 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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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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