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FDA 510(k)

FETAL-TEK CONTROL (IMMATURE/BORDERLINE)

K-Number: K820772 · 1982-05-12

ApplicantHelena Laboratories
Decision Date1982-05-12
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FETAL-TEK CONTROL (IMMATURE/BORDERLINE) is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1982-05-12 under 510(k) number K820772. 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 FETAL-TEK CONTROL (IMMATURE/BORDERLINE)?

FETAL-TEK CONTROL (IMMATURE/BORDERLINE) is a medical device that received FDA 510(k) clearance on 1982-05-12. The listed applicant is Helena Laboratories. The 510(k) number is K820772.

When did FETAL-TEK CONTROL (IMMATURE/BORDERLINE) receive FDA 510(k) clearance?

FETAL-TEK CONTROL (IMMATURE/BORDERLINE) received FDA 510(k) clearance on 1982-05-12, under 510(k) number K820772.

Who is the listed applicant for FETAL-TEK CONTROL (IMMATURE/BORDERLINE)?

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 FETAL-TEK CONTROL (IMMATURE/BORDERLINE)?

The FDA product code for FETAL-TEK CONTROL (IMMATURE/BORDERLINE) is JJX.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: 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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