FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MILES LIPASE SERA-PAK METHOD
K Number: K920337
·
Decision Mar 11, 1992
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
19
Applicant Total
145
Review Days
47
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Basic Information
- Device Name
- MILES LIPASE SERA-PAK METHOD
- K Number
- K920337
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- January 24, 1992
- Decision Date
- March 11, 1992
- Product Code
- CHI
- 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 |
|---|---|---|---|
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHI), ordered by most recent decision date.
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
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LIPASE-PS ASSAY PROCEDURE NO. 805
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Heraeus Kulzer, Inc.
| 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 |