SAF FECAL COLLECTION KIT— 510(k) K885244
Substantially EquivalentPrecision Biologicals, Inc.
FDA 510(k) clearance K885244 for SAF FECAL COLLECTION KIT, Substantially Equivalent on 1989-03-21. Applicant: Precision Biologicals, Inc.. Device class: 1.
Clearance details
- Applicant
- Precision Biologicals, Inc.
- Product code
- Code JSM
- Device class
- Class 1
- Regulation
- 21 CFR 866.2390
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dartmouth, CA
Recent devices under product code JSM
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- K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
- K971219 — CRYO CHECK INR VALIDATION SET
- K971222 — CRYO CHECK APC RESISTANT PLASMA
Data sourced from openFDA. This site is unofficial and independent of the FDA.