FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMASTIX REAGENT STRIPS
K Number: K905396
·
Decision Feb 11, 1991
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
10
Applicant Total
145
Review Days
73
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Basic Information
- Device Name
- HEMASTIX REAGENT STRIPS
- K Number
- K905396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- November 30, 1990
- Decision Date
- February 11, 1991
- Product Code
- JIO
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JIO | Blood, Occult, Colorimetric, In Urine | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIO), ordered by most recent decision date.
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
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MISSION U500 URINE ANALYZER
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WIENER LAB. URINE STRIP 10 AND 11
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URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
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| K Number | Device Name | ||
|---|---|---|---|
| K091494 | FLEXITIME FLOW | Jul 31, 2009 | Substantially Equivalent |
| K063062 | HKBOND 2006 | Dec 1, 2006 | Substantially Equivalent |
| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent |
| K052543 | HERACERAM ZIRKONIA | Oct 25, 2005 | Substantially Equivalent |
| K043504 | PALAIMPACT | Jan 28, 2005 | Substantially Equivalent |
| K043295 | VERSYO.DIRECT | Jan 5, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
| K040859 | HERACERAM PRESS | May 20, 2004 | Substantially Equivalent |
| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |