Biotecx Laboratories, Inc.
Mchenry, IL, US
Biotecx Laboratories, Inc. appears in FDA device records in Mchenry, IL. 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 Biotecx Laboratories, Inc. between 1978 and 1999. The busiest year on record is 1984, with 3. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 3 |
| 1998 | 1 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K982298 | OPTICOAT T4 EIA KIT | KLI | Substantially Equivalent | |
| K981824 | OPTICOAT T3 EIA KIT | CDP | Substantially Equivalent | |
| K895407 | CORTISOL CLASP-BEAD EIA KIT | CGR | Substantially Equivalent | |
| K893620 | T3 CLASP-BEAD EIA KIT | CDP | Substantially Equivalent | |
| K892853 | T4 CLASP-BEAD EIA KIT | KLI | Substantially Equivalent | |
| K883765 | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE | KHQ | Substantially Equivalent | |
| K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT | JLS | Substantially Equivalent | |
| K863188 | HPL RIA KIT | JMX | Substantially Equivalent | |
| K854876 | ALDOSTERONE DIRECT RIA KIT | KQN | Substantially Equivalent | |
| K851540 | ESTRADIOL DIRECT RIA KIT | CHP | Substantially Equivalent | |
| K844767 | RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO | CGI | Substantially Equivalent | |
| K842957 | CORITSOL PREMIX RIA KIT | CGR | Substantially Equivalent | |
| K842555 | DHEA-S DIRECT RIA KIT | JKC | Substantially Equivalent | |
| K841333 | PROGESTERONE DIRECT RIA KIT-RADIOIMM | JLS | Substantially Equivalent | |
| K780761 | ELECTRO-PLETHYSMOGRAPH | JOM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- JMXNinhydrin, Nitrogen (Amino-Nitrogen)
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
- KQNRadioassay, Angiotensin Converting Enzyme
- KHQRadioassay, Triiodothyronine Uptake
- CGRRadioimmunoassay, Cortisol
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- JLSRadioimmunoassay, Progesterone
- CDPRadioimmunoassay, Total Triiodothyronine
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain