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FDA 510(k)

SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479

K-Number: K924915 · 1992-12-18

ApplicantHelena Laboratories
Decision Date1992-12-18
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1992-12-18 under 510(k) number K924915. 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 SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479?

SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 is a medical device that received FDA 510(k) clearance on 1992-12-18. The listed applicant is Helena Laboratories. The 510(k) number is K924915.

When did SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 receive FDA 510(k) clearance?

SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 received FDA 510(k) clearance on 1992-12-18, under 510(k) number K924915.

Who is the listed applicant for SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479?

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 SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479?

The FDA product code for SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 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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