Selfcare, Inc.
Waltham, MA, US
Selfcare, Inc. appears in FDA device records in Waltham, MA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Selfcare, Inc. between 1996 and 2000. The busiest year on record is 1999, with 5. The most recent is 2000, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 5 |
| 2000 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | CEP | Substantially Equivalent | |
| K002134 | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K002049 | INVERNESS MEDICAL EARLY PREGNANCY TEST | LCX | Substantially Equivalent | |
| K001427 | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K000583 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K993632 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K991480 | EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP | CGA | Substantially Equivalent | |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | CEP | Substantially Equivalent | |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | CEP | Substantially Equivalent | |
| K990939 | FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K983468 | FASTTAKE ADAPTER, MODEL # P/N 020-072-01 | JQP | Substantially Equivalent | |
| K970707 | ELECT II BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K961985 | ELECT BLOOD GLUCOSE MONITORIG SYSTEM | CGA | Substantially Equivalent | |
| K960053 | SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM | CGA | Substantially Equivalent | |
| K960436 | SELFCARE EARLY PREGNANCY TEST | LCX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Selfcare, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Selfcare, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain