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FDA 510(k)

ULTRASCAN CLINICAL ANALYZER

K-Number: K862999 · 1986-09-15

ApplicantSpecialty Medical Industries, Inc.
Decision Date1986-09-15
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRASCAN CLINICAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Medical Industries, Inc.. It received FDA 510(k) clearance on 1986-09-15 under 510(k) number K862999. 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 ULTRASCAN CLINICAL ANALYZER?

ULTRASCAN CLINICAL ANALYZER is a medical device that received FDA 510(k) clearance on 1986-09-15. The listed applicant is Specialty Medical Industries, Inc.. The 510(k) number is K862999.

When did ULTRASCAN CLINICAL ANALYZER receive FDA 510(k) clearance?

ULTRASCAN CLINICAL ANALYZER received FDA 510(k) clearance on 1986-09-15, under 510(k) number K862999.

Who is the listed applicant for ULTRASCAN CLINICAL ANALYZER?

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

What is the FDA product code for ULTRASCAN CLINICAL ANALYZER?

The FDA product code for ULTRASCAN CLINICAL ANALYZER is JJQ.

Related Clinical Trials

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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Other records listing Specialty Medical Industries, 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.

K872968ULTRASCAN IGE ASSAY KITK790808PROTEIN ASSAY KIT

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, Inc.

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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