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FDA 510(k)

EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST

K-Number: K861221 · 1986-04-24

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-04-24
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1986-04-24 under 510(k) number K861221. 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 EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST?

EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K861221.

When did EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST receive FDA 510(k) clearance?

EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST received FDA 510(k) clearance on 1986-04-24, under 510(k) number K861221.

Who is the listed applicant for EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST?

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

What is the FDA product code for EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST?

The FDA product code for EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST is JJX.

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Other records listing Em Diagnostic Systems, 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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