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FDA 510(k)

PERMACLEAR SOLUTION CAT. NO. 4950

K-Number: K861490 · 1986-05-06

ApplicantHelena Laboratories
Decision Date1986-05-06
Product CodeKEM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PERMACLEAR SOLUTION CAT. NO. 4950 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1986-05-06 under 510(k) number K861490. The device is classified under product code KEM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMACLEAR SOLUTION CAT. NO. 4950?

PERMACLEAR SOLUTION CAT. NO. 4950 is a medical device that received FDA 510(k) clearance on 1986-05-06. The listed applicant is Helena Laboratories. The 510(k) number is K861490.

When did PERMACLEAR SOLUTION CAT. NO. 4950 receive FDA 510(k) clearance?

PERMACLEAR SOLUTION CAT. NO. 4950 received FDA 510(k) clearance on 1986-05-06, under 510(k) number K861490.

Who is the listed applicant for PERMACLEAR SOLUTION CAT. NO. 4950?

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 PERMACLEAR SOLUTION CAT. NO. 4950?

The FDA product code for PERMACLEAR SOLUTION CAT. NO. 4950 is KEM.

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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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: KEM)

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.

K881282XYLENEAnatech, Ltd.K874461HEMO-SOLChem Pharm, Inc.K855109CLEARENE, CLEARING AGENTSurgipath Medical Industries, Inc.K854083XYLENE SUBSTITUTE MONTANTLerner Laboratories, Inc.K853694XYLENE SUBSTITUTELerner Laboratories, Inc.K842861PRO-PAR CLEARANTAnatech, Ltd.

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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