FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLINISTAT LDH REAGENT TEST
K Number: K895138
·
Decision Oct 19, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
145
Review Days
64
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Basic Information
- Device Name
- CLINISTAT LDH REAGENT TEST
- K Number
- K895138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- August 16, 1989
- Decision Date
- October 19, 1989
- Product Code
- CFH
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CFH | Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFH), ordered by most recent decision date.
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LACTATE DEHYDROGENASE (LDH) REAGENT SET
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EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Heraeus Kulzer, Inc.
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|---|---|---|---|
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| 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 |