FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
K Number: K893548
·
Decision Aug 3, 1989
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
145
Review Days
87
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Basic Information
- Device Name
- SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
- K Number
- K893548
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- May 8, 1989
- Decision Date
- August 3, 1989
- Product Code
- LBS
- 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 |
|---|---|---|---|
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| 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 |