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FDA 510(k)

8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.

K-Number: K802164 · 1980-10-10

ApplicantPanmed, Inc.
Decision Date1980-10-10
Product CodeCIC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. is the device name listed in this FDA 510(k) record. The listed applicant is Panmed, Inc.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802164. The device is classified under product code CIC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.?

8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Panmed, Inc.. The 510(k) number is K802164.

When did 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. receive FDA 510(k) clearance?

8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802164.

Who is the listed applicant for 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.?

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

What is the FDA product code for 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM.?

The FDA product code for 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. is CIC.

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Other records listing Panmed, 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.

K852767ERYTHOCYTE CREATINEK820642SICKLE-CHECKK802161BIURET REAGENT & TOTAL PROTEIN BLANK SOLK802157BCG REAGENT SERUM ALBUMIN W/TECHNICONK802163CHLORIDE COLOR & CHLORIDE SAMPLE DILUENTK802155REAGENTS SERUM SODIUM USING THE TECH.

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Related Devices (Code: CIC)

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.

K130870HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)Hitachi Chemical Diagnostics, Inc.K083339DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)Siemens Healthcare Diagnostics, Inc.K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba AbxK053401SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTSArkray, Inc.K050077SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTSArkray, Inc.K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTHemagen Diagnostics, Inc.

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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