Lancer Ice Cube
FDA 510(k) K782077 · Sherwood Medical Industries
510(k) numberK782077
Submission
- Device name
- Lancer Ice Cube
- Applicant
- Sherwood Medical Industries
Mchenry, IL, US - Received
- December 13, 1978
- Decision date
- April 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JRM – Freezer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921570 | ORS-300JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K921569 | ORS-200JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K921568 | ORS-100JRM · Traditional | Mnlase, Inc. | 06/09/1992SE |
| K915427 | ORS-1000JRM · Traditional | Mnlase, Inc. | 01/07/1992SE |
| K913777 | Self-Contained Surgical Slush FreezerJRM · Traditional | Taylor Corp. | 09/25/1991SE |
| K894006 | Saniserv Surgical Slush SystemJRM · Traditional | Saniserv, Inc. | 11/03/1989SE |
More from Saniserv, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801070 | Sherwood Disposable Endometrial SamplesHHK · Traditional | 07/21/1980SE |
| K801071 | Lancer Glucose Rate Reagent KitCGA · Traditional | 05/23/1980SE |
| K792014 | Lancer L-Ina Buffer, Polymer, Wash SoluJZW · Traditional | 11/13/1979SE |
| K792013 | Lancer L-Ina Human Reference SerumJIX · Traditional | 11/13/1979SE |
| K790523 | Argyle Esophageal StethoscopeBZW · Traditional | 03/27/1979SE |
| K790196 | Monoject Arterial Blood Sampling DeviceCBT · Traditional | 03/13/1979SE |
| K790197 | Reagent Kit, Lancer GlucoseJJF · Traditional | 03/12/1979SE |
| K781459 | Monoject Scale MagnifierHJY · Traditional | 10/24/1978SE |
| K781060 | Monoject Endosseous Dental ImplantDZE · Traditional | 08/14/1978SE |
| K772149 | Lancer Biopsy HolderKER · Traditional | 11/22/1977SE |
Questions and answers
When was Lancer Ice Cube cleared by the FDA?
Lancer Ice Cube (K782077) received a 510(k) decision of Substantially Equivalent on April 3, 1979, 111 days after the submission was received.
What is the product code of K782077?
The FDA product code is JRM – Freezer, a Class I (low risk) device regulated under 21 CFR 862.2050.