FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
K Number: K990250
·
Decision Jun 18, 1999
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
7
Applicant Total
12
Review Days
143
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Basic Information
- Device Name
- HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
- K Number
- K990250
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Morax
- Date Received
- January 26, 1999
- Decision Date
- June 18, 1999
- Product Code
- LBT
- 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 |
|---|---|---|---|
| LBT | Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
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Other Clearances by Morax
| K Number | Device Name | ||
|---|---|---|---|
| K033277 | HYDRAGEL CSF ISOFOCUSING KITS | Nov 4, 2003 | Substantially Equivalent |
| K012789 | MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 | Jan 17, 2002 | Substantially Equivalent |
| K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT | Dec 29, 1999 | Substantially Equivalent |
| K991362 | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) | Jun 21, 1999 | Substantially Equivalent |
| K981048 | HYDRAGEL 6 CSF KIT | Oct 7, 1998 | Substantially Equivalent |
| K974854 | HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 | Oct 7, 1998 | Substantially Equivalent |
| K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT | Mar 4, 1998 | Substantially Equivalent |
| K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT | Oct 27, 1997 | Substantially Equivalent |
| K963844 | HYDRAGEL 15 HB A1C KIT | Apr 22, 1997 | Substantially Equivalent |
| K960029 | HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT | Jul 17, 1996 | Substantially Equivalent |