FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ERYTHOCYTE CREATINE
K Number: K852767
·
Decision Nov 13, 1986
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
1
Applicant Total
16
Review Days
503
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Basic Information
- Device Name
- ERYTHOCYTE CREATINE
- K Number
- K852767
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1210
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Panmed, Inc.
- Date Received
- June 28, 1985
- Decision Date
- November 13, 1986
- Product Code
- JLA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JLA | Conversion To Creatinine, Creatine | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLA), ordered by most recent decision date.
View allOther Clearances by Panmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K820642 | SICKLE-CHECK | Apr 14, 1982 | Substantially Equivalent |
| K802155 | REAGENTS SERUM SODIUM USING THE TECH. | Oct 10, 1980 | Substantially Equivalent |
| K802158 | POSTASSIUM BUFFER SOL. & WASH SOLUTION | Oct 10, 1980 | Substantially Equivalent |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent |
| K802156 | REAGENTS SERUM CREATINE USING TECHICON | Oct 10, 1980 | Substantially Equivalent |
| K802163 | CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent |
| K802157 | BCG REAGENT SERUM ALBUMIN W/TECHNICON | Oct 10, 1980 | Substantially Equivalent |
| K802159 | AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS | Oct 10, 1980 | Substantially Equivalent |
| K802160 | BUN COLOR REAGENT & BUN ACID USED | Oct 10, 1980 | Substantially Equivalent |
| K802164 | 8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. | Oct 10, 1980 | Substantially Equivalent |