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FDA 510(k)

PROTOPORPHYRIN ZN CONTROL

K-Number: K830493 · 1983-04-18

ApplicantKaulson Laboratories, Inc.
Decision Date1983-04-18
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROTOPORPHYRIN ZN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Kaulson Laboratories, Inc.. It received FDA 510(k) clearance on 1983-04-18 under 510(k) number K830493. 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 PROTOPORPHYRIN ZN CONTROL?

PROTOPORPHYRIN ZN CONTROL is a medical device that received FDA 510(k) clearance on 1983-04-18. The listed applicant is Kaulson Laboratories, Inc.. The 510(k) number is K830493.

When did PROTOPORPHYRIN ZN CONTROL receive FDA 510(k) clearance?

PROTOPORPHYRIN ZN CONTROL received FDA 510(k) clearance on 1983-04-18, under 510(k) number K830493.

Who is the listed applicant for PROTOPORPHYRIN ZN CONTROL?

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

What is the FDA product code for PROTOPORPHYRIN ZN CONTROL?

The FDA product code for PROTOPORPHYRIN ZN CONTROL is JJX.

Related Clinical Trials

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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Other records listing Kaulson Laboratories, 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.

K830494CONTOX DRUG SCREEN CONTROLK830492CONTOX DURG CONTROLK830234CONTOX HEAVYMETALS CONTROL

Related Devices (Code: JJX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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