Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

GMI 1979-08-16

CANDIDA IMMUNODIFFUSION KIT #CA1001

Applicant Immuno-Mycologics, Inc.

K-Number K791383

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DFZ 1979-08-16

ANTISERUM TO RABBIT IMMUNOGLOBULIN

Applicant Kent Laboratories, Inc.

K-Number K790709

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IKN 1979-08-16

CADWELL 7000 ELECTROMYOGRAPH MACHINE

Applicant Cadwell Laboratories, Inc.

K-Number K791235

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KFG 1979-08-16

ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM

Applicant Immuno-Mycologics, Inc.

K-Number K791386

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KCT 1979-08-16

DISPOSABLE INSTRUMENT TRAY PAD

Applicant Anago, Inc.

K-Number K791412

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JEC 1979-08-16

ACE EXTERNAL BONE CLAMP PART #S11

Applicant Ace Orthopedic Manufacturing Co.

K-Number K791466

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JIT 1979-08-16

CATALOG #4-2520 CHLORIDOMETER CHLORIDE

Applicant Buchler Instruments, Inc.

K-Number K791312

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GMG 1979-08-16

COCCIDIODES (COCCI)

Applicant Immuno-Mycologics, Inc.

K-Number K791381

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ISB 1979-08-16

GALVANIC UNIT

Applicant Rami International Corp.

K-Number K790949

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GMJ 1979-08-16

HISTOPLASMA MYCELIAL #CF10020X

Applicant Immuno-Mycologics, Inc.

K-Number K791394

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HST 1979-08-16

MEDI-TRAK PORTABLE TRACTION DEVICE

Applicant Medicorp, Inc.

K-Number K791396

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DAS 1979-08-16

ANTISERUM TO HUMAN FC

Applicant Kent Laboratories, Inc.

K-Number K790715

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