Pantex, Div. Bio-Analysis, Inc.
Santa Monica, CA, US
Pantex, Div. Bio-Analysis, Inc. appears in FDA device records in Santa Monica, CA. FDA records list 16 510(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
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Pantex, Div. Bio-Analysis, Inc. between 1981 and 2012. The busiest year on record is 1991, with 5. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 1 |
| 1989 | 1 |
| 1991 | 5 |
| 1995 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102841 | PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY | NHG | Substantially Equivalent | |
| K942658 | NEOSCREEN ELISA TSH | JLW | Substantially Equivalent | |
| K914107 | PROLACTIN IRMA IMMUNOMAG | CFT | Substantially Equivalent | |
| K912804 | FSH IRMA IMMUNOMAG | CGJ | Substantially Equivalent | |
| K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | JLX | Substantially Equivalent | |
| K911050 | LH IRMA IMMUNOMAG | CEP | Substantially Equivalent | |
| K910717 | PANTEX IRMA LH 1251 KIT | CEP | Substantially Equivalent | |
| K894049 | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT | JLS | Substantially Equivalent | |
| K862483 | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT | CDZ | Substantially Equivalent | |
| K862447 | PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT | KHQ | Substantially Equivalent | |
| K862336 | PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT | CGR | Substantially Equivalent | |
| K854324 | PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT | CDX | Substantially Equivalent | |
| K853866 | PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS | CHP | Substantially Equivalent | |
| K853865 | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO | CDZ | Substantially Equivalent | |
| K853867 | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | JKC | Substantially Equivalent | |
| K810204 | 17B ESTRADIOL | CHP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- NHGEnzyme Immunoassay, Cortisol, Salivary
- KHQRadioassay, Triiodothyronine Uptake
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CGRRadioimmunoassay, Cortisol
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
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.
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Data as of , FDA export datePage updated Source: openFDA, public domain