510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Chemtron Biotech, Inc.

San Diego, CA, US

Chemtron Biotech, Inc. appears in FDA device records in San Diego, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Chemtron Biotech, Inc. between 2011 and 2023. The busiest year on record is 2011, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Chemtron Biotech, Inc., by decision year
YearClearances
20112
20122
20132
20142
20151
20161
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card TestDJGSubstantially Equivalent
K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsDJGSubstantially Equivalent
K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000DJGSubstantially Equivalent
K142580Chemtrue Multi-Panel DOA DIP Card TestsDKZSubstantially Equivalent
K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsDJGSubstantially Equivalent
K131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TESTLCXSubstantially Equivalent
K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TESTJHISubstantially Equivalent
K123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSJXMSubstantially Equivalent
K121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTSDKZSubstantially Equivalent
K111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARDJXMSubstantially Equivalent
K102203CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTSDKZSubstantially Equivalent

Registered establishments

FDA registered establishments for Chemtron Biotech, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30088523063008852306Chemtron Biotech, Inc.9245 Brown Deer Rd Ste B, San Diego, CA 92121 US2026and 14 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

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.

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Data as of , FDA export datePage updated Source: openFDA, public domain