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FDA 510(k)

BIOTEL (TM)/ DIABETES

K-Number: K855239 · 1986-06-13

ApplicantAmerican Diagnostic Corp.
Decision Date1986-06-13
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTEL (TM)/ DIABETES is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1986-06-13 under 510(k) number K855239. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEL (TM)/ DIABETES?

BIOTEL (TM)/ DIABETES is a medical device that received FDA 510(k) clearance on 1986-06-13. The listed applicant is American Diagnostic Corp.. The 510(k) number is K855239.

When did BIOTEL (TM)/ DIABETES receive FDA 510(k) clearance?

BIOTEL (TM)/ DIABETES received FDA 510(k) clearance on 1986-06-13, under 510(k) number K855239.

Who is the listed applicant for BIOTEL (TM)/ DIABETES?

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

What is the FDA product code for BIOTEL (TM)/ DIABETES?

The FDA product code for BIOTEL (TM)/ DIABETES is JIL.

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Other records listing American Diagnostic Corp. as applicant

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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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