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FDA 510(k)

HELENA FETAL-TEK 200 MARKER

K-Number: K811695 · 1981-07-01

ApplicantHelena Laboratories
Decision Date1981-07-01
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HELENA FETAL-TEK 200 MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1981-07-01 under 510(k) number K811695. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA FETAL-TEK 200 MARKER?

HELENA FETAL-TEK 200 MARKER is a medical device that received FDA 510(k) clearance on 1981-07-01. The listed applicant is Helena Laboratories. The 510(k) number is K811695.

When did HELENA FETAL-TEK 200 MARKER receive FDA 510(k) clearance?

HELENA FETAL-TEK 200 MARKER received FDA 510(k) clearance on 1981-07-01, under 510(k) number K811695.

Who is the listed applicant for HELENA FETAL-TEK 200 MARKER?

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

What is the FDA product code for HELENA FETAL-TEK 200 MARKER?

The FDA product code for HELENA FETAL-TEK 200 MARKER is JJY.

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Other records listing Helena Laboratories 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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Related Devices (Code: JJY)

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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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