FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LANCER ICE CUBE
K Number: K782077
·
Decision Apr 3, 1979
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
6
Applicant Total
62
Review Days
111
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Basic Information
- Device Name
- LANCER ICE CUBE
- K Number
- K782077
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Industries
- Date Received
- December 13, 1978
- Decision Date
- April 3, 1979
- Product Code
- JRM
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| JRM | Freezer | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRM), ordered by most recent decision date.
ORS-100
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ORS-300
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ORS-200
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ORS-1000
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SELF-CONTAINED SURGICAL SLUSH FREEZER
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SANISERV SURGICAL SLUSH SYSTEM
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Other Clearances by Sherwood Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K801070 | SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES | Jul 21, 1980 | Substantially Equivalent |
| K801071 | LANCER GLUCOSE RATE REAGENT KIT | May 23, 1980 | Substantially Equivalent |
| K792013 | LANCER L-INA HUMAN REFERENCE SERUM | Nov 13, 1979 | Substantially Equivalent |
| K792014 | LANCER L-INA BUFFER, POLYMER, WASH SOLU | Nov 13, 1979 | Substantially Equivalent |
| K790523 | ARGYLE ESOPHAGEAL STETHOSCOPE | Mar 27, 1979 | Substantially Equivalent |
| K790196 | MONOJECT ARTERIAL BLOOD SAMPLING DEVICE | Mar 13, 1979 | Substantially Equivalent |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Mar 12, 1979 | Substantially Equivalent |
| K781459 | MONOJECT SCALE MAGNIFIER | Oct 24, 1978 | Substantially Equivalent |
| K781060 | MONOJECT ENDOSSEOUS DENTAL IMPLANT | Aug 14, 1978 | Substantially Equivalent |
| K772149 | LANCER BIOPSY HOLDER | Nov 22, 1977 | Substantially Equivalent |