THROMBOPLASTIN— 510(k) K884855
Substantially EquivalentPrecision Biologicals, Inc.
FDA 510(k) clearance K884855 for THROMBOPLASTIN, Substantially Equivalent on 1989-01-30. Applicant: Precision Biologicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Precision Biologicals, Inc.
- Product code
- Code GJS
- Device class
- Class 2
- Regulation
- 21 CFR 864.7750
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dartmouth, CA
Recent devices under product code GJS
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view all- K981173 — CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
- K981174 — CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
- K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
- K971219 — CRYO CHECK INR VALIDATION SET
- K971222 — CRYO CHECK APC RESISTANT PLASMA
Adverse events under product code GJS
product code GJS- Death
- 4
- Injury
- 229
- Malfunction
- 4,852
- Total
- 5,085
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.