Master Kit B
FDA 510(k) K861142 · Pro-Lab, Inc.
510(k) numberK861142
Submission
- Device name
- Master Kit B
- Applicant
- Pro-Lab, Inc.
Birmingham, AL, US - Received
- March 26, 1986
- Decision date
- July 10, 1986
- Decision
- Unknown (SESD)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRP – Tray, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LRP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963723 | Laceration TrayLRP · Traditional | Grand Medical Products | 11/27/1996SE |
| K951811 | Osteotech Musculoskeletal Tissue Recovery PackLRP · Traditional | Osteotech, Inc. | 05/31/1995SE |
| K940239 | Eye TrayLRP · Traditional | Cush Medical Products | 06/28/1994SEKD |
| K935621 | Custom ENT PacksLRP · Traditional | Associated Medical | 03/30/1994SE |
| K940646 | Orthopedic Tray Product LineLRP · Traditional | Cushindu | 03/11/1994SEKD |
| K940444 | General Surgery TrayLRP · Traditional | Cush Medical Products | 03/07/1994SEKD |
| K922126 | Hospital Kit ENT 1125LRP · Traditional | Savoy Medical Supply Co., Inc. | 01/21/1993SE |
| K912105 | Eye TrayLRP · Traditional | Medical Device Inspection Co., Inc. | 08/29/1991SE |
| K903963 | Kits and Trays for One Time Use OnlyLRP · Traditional | Apk Technology | 07/29/1991SEKD |
| K903962 | Instruments for One Time Use/ DisposableLRP · Traditional | Apk Technology | 07/29/1991SEKD |
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| K934383 | Prolex (Streptoccal Grouping Latex Kit)GTZ · Traditional | 01/27/1995SE |
| K914419 | Amniotest(Tm)HIO · Traditional | 09/01/1993SE |
| K921421 | Legionella Reagens for Direct Fluorescent AntibodyLHL · Traditional | 07/28/1992SE |
| K903714 | E. Coli 0157 Latex TestGNA · Traditional | 01/24/1991SE |
| K894221 | Rosco PyrrJTO · Traditional | 09/28/1989SE |
| K883996 | X-Act Ldc/IndJSE · Traditional | 10/12/1988SE |
| K883995 | X-Act Urea/TdaJSE · Traditional | 10/12/1988SE |
| K871121 | Protect T.M.JTR · Traditional | 04/14/1987SE |
| K870117 | Neisseria/Branhamella Differential TestJSX · Traditional | 03/20/1987SE |
| K861889 | D'Ala Rapid TestJTO · Traditional | 06/03/1986SE |
Questions and answers
When was Master Kit B cleared by the FDA?
Master Kit B (K861142) received a 510(k) decision of Unknown on July 10, 1986, 106 days after the submission was received.
What is the product code of K861142?
The FDA product code is LRP – Tray, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.