Soluble Collagen

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K780285 ↗

FDA Product Code

JOZ

Device Class

Class II

Regulation

21 CFR Part 864.5700

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from General Diagnostics →

• What is the Soluble Collagen device used for?

  The Soluble Collagen device is used for measuring soluble collagen in various sample types and is intended for use in hematology-related laboratory testing, as specified in its description and classification under System, Automated Platelet Aggregation.

• How is the Soluble Collagen device supplied and by whom?

  The Soluble Collagen device is supplied by General Diagnostics, as stated in the manufacturer and applicant fields, and is distributed from their address in Mchenry, Illinois, with no indication of sterile or single-use labeling in the provided data.

• What regulatory pathway was used for the Soluble Collagen device?

  The Soluble Collagen device received FDA 510(k) clearance via the traditional pathway, as indicated by the authorization type FDA_510K and clearance_type: Traditional, with K780285 granted on March 30, 1978, based on substantial equivalence.

• What is the classification and regulatory identifier for the Soluble Collagen device?

  The Soluble Collagen device is classified as Class II under FDA regulation number 864.5700, with product code JOZ, and is categorized as a System, Automated Platelet Aggregation device, as reflected in the openfda and classification fields.