FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
SAF FECAL COLLECTION KIT
K Number: K885244
·
Decision Mar 21, 1989
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
20
Review Days
89
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Basic Information
- Device Name
- SAF FECAL COLLECTION KIT
- K Number
- K885244
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Precision Biologicals, Inc.
- Date Received
- December 22, 1988
- Decision Date
- March 21, 1989
- Product Code
- JSM
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
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Other Clearances by Precision Biologicals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | Jan 13, 1999 | Substantially Equivalent |
| K982062 | CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 | Jan 13, 1999 | Substantially Equivalent |
| K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | Jan 13, 1999 | Substantially Equivalent |
| K971219 | CRYO CHECK INR VALIDATION SET | Aug 29, 1997 | Substantially Equivalent |
| K971222 | CRYO CHECK APC RESISTANT PLASMA | Aug 19, 1997 | Substantially Equivalent |
| K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA | Jul 22, 1997 | Substantially Equivalent |
| K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA | Jul 18, 1997 | Substantially Equivalent |
| K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA | Jul 18, 1997 | Substantially Equivalent |
| K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA | Jul 17, 1997 | Substantially Equivalent |
| K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA | Jul 17, 1997 | Substantially Equivalent |