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FDA 510(k)

QUIDEL REFLECTANCE ANALYZER

K-Number: K893738 · 1989-08-11

ApplicantQuidel Corp.
Decision Date1989-08-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIDEL REFLECTANCE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K893738. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIDEL REFLECTANCE ANALYZER?

QUIDEL REFLECTANCE ANALYZER is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Quidel Corp.. The 510(k) number is K893738.

When did QUIDEL REFLECTANCE ANALYZER receive FDA 510(k) clearance?

QUIDEL REFLECTANCE ANALYZER received FDA 510(k) clearance on 1989-08-11, under 510(k) number K893738.

Who is the listed applicant for QUIDEL REFLECTANCE ANALYZER?

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

What is the FDA product code for QUIDEL REFLECTANCE ANALYZER?

The FDA product code for QUIDEL REFLECTANCE ANALYZER is JJQ.

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Other records listing Quidel Corp. as applicant

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K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+B

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Related Devices (Code: JJQ)

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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