Serono-Baker Diagnostics, Inc.
Winchester, VA, US
Serono-Baker Diagnostics, Inc. appears in FDA device records in Winchester, VA. FDA records list 23 510(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
- 23
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 23 510(k) clearances for Serono-Baker Diagnostics, Inc. between 1988 and 1992. The busiest year on record is 1991, with 10. The most recent is 1992, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 2 |
| 1989 | 7 |
| 1991 | 10 |
| 1992 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY | CDZ | Substantially Equivalent | |
| K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY | CDZ | Substantially Equivalent | |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | CGR | Substantially Equivalent | |
| K915602 | SRI DIGOXIN ENZYME IMMUNOASSAY | KXT | Substantially Equivalent | |
| K912937 | SR1 FREE T4 ENZYME IMMUNOASSAY | CEC | Substantially Equivalent | |
| K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) | JLS | Substantially Equivalent | |
| K911912 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) | KHQ | Substantially Equivalent | |
| K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) | KLI | Substantially Equivalent | |
| K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) | CHP | Substantially Equivalent | |
| K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY | CHP | Substantially Equivalent | |
| K910837 | SRI TSH IMMUNENZYMETRIC ASSAY | JLW | Substantially Equivalent | |
| K910737 | SRI T3 IMMOENZYMETRIC ASSAY | CDP | Substantially Equivalent | |
| K911175 | SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) | DBF | Substantially Equivalent | |
| K903975 | SEROZYME CORTISOL TEST KIT | CGR | Substantially Equivalent | |
| K896145 | ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY | CHP | Substantially Equivalent | |
| K894175 | SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY | JHI | Substantially Equivalent | |
| K895380 | SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY | CFT | Substantially Equivalent | |
| K893605 | SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY | CEP | Substantially Equivalent | |
| K892706 | SR1 (FSH) IMMUNOENZYMETRIC ASSAY | CGJ | Substantially Equivalent | |
| K890645 | ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT | CHP | Substantially Equivalent | |
| K884794 | PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY | JLS | Substantially Equivalent | |
| K884683 | FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY | DBF | Substantially Equivalent | |
| K883539 | SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER | JJE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- KXTEnzyme Immunoassay, Digoxin
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DBFFerritin, Antigen, Antiserum, Control
- KHQRadioassay, Triiodothyronine Uptake
- CGRRadioimmunoassay, Cortisol
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- JHIVisual, Pregnancy Hcg, Prescription Use
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 Serono-Baker Diagnostics, 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 Serono-Baker Diagnostics, 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