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FDA 510(k)

IP SPECIFIC G

K-Number: K830005 · 1983-06-02

ApplicantDiagnostic Reagent Tech.
Decision Date1983-06-02
Product CodeDAA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IP SPECIFIC G is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagent Tech.. It received FDA 510(k) clearance on 1983-06-02 under 510(k) number K830005. The device is classified under product code DAA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IP SPECIFIC G?

IP SPECIFIC G is a medical device that received FDA 510(k) clearance on 1983-06-02. The listed applicant is Diagnostic Reagent Tech.. The 510(k) number is K830005.

When did IP SPECIFIC G receive FDA 510(k) clearance?

IP SPECIFIC G received FDA 510(k) clearance on 1983-06-02, under 510(k) number K830005.

Who is the listed applicant for IP SPECIFIC G?

The FDA 510(k) record lists Diagnostic Reagent Tech. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IP SPECIFIC G?

The FDA product code for IP SPECIFIC G is DAA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diagnostic Reagent Tech. 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.

K843302NEW ALLERG. COATED MICROFILTER WELL STRIK832345POLYSTYRENE MICROTITER WELL IMMUNOSORK831984POLYSTYRENE MICRO-LITER PLATE-BIRCHTREEK832344POLYSTYRENE MICROTITER PLATE IMMUNO-K831496ALLERGEN IMMUNOSORBENTS IP SPECIFIC EK831774LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-

View all 10 devices →

Related Devices (Code: DAA)

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.

K832675ANA MICROZYME TEST SYS #1610Clinical Sciences, Inc.K831927ANTINUCLEAR ANTIBODY TEST KITBreit Laboratories, Inc.K822911ANAZYME ANA PEROXIDASE TEST SYSTEMClinical Sciences, Inc.K791749INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROLClinical Sciences, 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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