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FDA 510(k)

DIASCAN CONTROL

K-Number: K853553 · 1985-09-16

ApplicantHome Diagnostics, Inc.
Decision Date1985-09-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIASCAN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Home Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K853553. 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 DIASCAN CONTROL?

DIASCAN CONTROL is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K853553.

When did DIASCAN CONTROL receive FDA 510(k) clearance?

DIASCAN CONTROL received FDA 510(k) clearance on 1985-09-16, under 510(k) number K853553.

Who is the listed applicant for DIASCAN CONTROL?

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

What is the FDA product code for DIASCAN CONTROL?

The FDA product code for DIASCAN CONTROL is JJX.

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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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