FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HDL CHOLESTEROL REAGENT
K Number: K911406
·
Decision May 22, 1991
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
27
Review Days
54
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Basic Information
- Device Name
- HDL CHOLESTEROL REAGENT
- K Number
- K911406
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Genzyme Corp.
- Date Received
- March 29, 1991
- Decision Date
- May 22, 1991
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
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Other Clearances by Genzyme Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | Jun 25, 2004 | Substantially Equivalent |
| K040868 | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH | Jun 4, 2004 | Substantially Equivalent |
| K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST | Apr 2, 2004 | Substantially Equivalent |
| K023544 | GENZYME CONTRAST II HCG URINE/SERUM TEST | Jan 16, 2003 | Substantially Equivalent |
| K021316 | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR | Jul 25, 2002 | Substantially Equivalent |
| K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE | Jun 18, 2002 | Substantially Equivalent |
| K012532 | SEPRAGEL SINUS | Oct 30, 2001 | Substantially Equivalent |
| K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT | Aug 10, 2001 | Substantially Equivalent |