FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUID SAMPLING PACK
K Number: K874436
·
Decision Jan 5, 1988
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
5
Applicant Total
5
Review Days
69
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Basic Information
- Device Name
- FLUID SAMPLING PACK
- K Number
- K874436
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.9050
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- U.S. Mfg. & Management, Inc.
- Date Received
- October 28, 1987
- Decision Date
- January 5, 1988
- Product Code
- KSS
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KSS | Supplies, Blood-Bank | FDA class 1 | Hematology |
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Other Clearances by U.S. Mfg. & Management, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920860 | CONTROLLED PASSIVE MOTION MACHINE | Apr 2, 1992 | Substantially Equivalent |
| K862335 | MODIFIED I.V. START, RE-START, PEDI AND GERI-KIT | Jul 24, 1986 | Substantially Equivalent for Some Indications |
| K853242 | I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI | Aug 30, 1985 | Unknown |
| K842999 | VENI-SHIELD | Sep 24, 1984 | Substantially Equivalent |