Microlyte 7
by The Rupp & Bowman Co. 510(k)
Active
510(k) K880973
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880973 | Date7 Sep 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JFP
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1145
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is an electrode, ion specific, calcium, as defined in the device name and openFDA data. It is a substantially equivalent device cleared via the traditional 510(k) pathway.
It was manufactured by The Rupp & Bowman Co. and received FDA 510(k) clearance under K880973 on September 7, 1988. The device is classified under regulation number 862.1145 and product code JFP, with medical specialty in clinical chemistry.
Other devices from The Rupp & Bowman Co.
Questions
AI-generated answers, 19 Sep 2026
What is the MICROLYTE 7 device used for?
The MICROLYTE 7 is an ion-specific electrode designed to measure calcium levels in clinical chemistry settings, as defined by its device name and classification under regulation number 862.1145 and product code JFP.
Who manufactures the MICROLYTE 7 and where are they located?
The MICROLYTE 7 is manufactured by The Rupp & Bowman Co., located at 9206 Royal Ln., Irving, TX 75063, United States.
How was the MICROLYTE 7 cleared for market entry in the United States?
The MICROLYTE 7 received FDA 510(k) clearance via the traditional pathway under submission K880973, which was granted on September 7, 1988, after being found substantially equivalent to a predicate device.
What regulatory classification and product code apply to the MICROLYTE 7?
The MICROLYTE 7 is classified as a Class II medical device under regulation number 862.1145 and assigned product code JFP, with its medical specialty designated as clinical chemistry.
What identifiers are associated with the MICROLYTE 7 in FDA databases?
The MICROLYTE 7 is associated with multiple FEI numbers and registration numbers in the openFDA data, including 3005643513, 3014506106, 3003971136, and others, which link to the manufacturer’s facilities and device listings.