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

San Diego, CA, US

GENBIO appears in FDA device records in San Diego, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Genbio carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Innominata Dba Genbioenforcement report, recall

510(k) clearance history

FDA records hold 10 510(k) clearances for Genbio between 1996 and 2001. The busiest year on record is 1998, with 5. The most recent is 2001, with 1.

Clearances by year, as a table
510(k) clearance decisions for Genbio, by decision year
YearClearances
19962
19972
19985
20011
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K010301IMMUNOWELL EA (D) IGG TESTLSESubstantially Equivalent
K974244IMMUNODOT MONO-M TESTLSESubstantially Equivalent
K974226IMMUNODOT MONO-G TESTLSESubstantially Equivalent
K973941IMMUNOWELL EBNA IGG TESTLLMSubstantially Equivalent
K973940IMMUNOWELL EBV VCA IGG TESTLSESubstantially Equivalent
K973939IMMUNOWELL VCA IGM TESTLJNSubstantially Equivalent
K963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)LJZSubstantially Equivalent
K963055IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120LJZSubstantially Equivalent
K953683MMUNO DOT BORRELIA DOT BLOT M TESTLSRSubstantially Equivalent
K953682IMMUNO DOT BORRELIA DOT BLOT G TESTLSRSubstantially Equivalent

Registered establishments

FDA registered establishments for Genbio, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20271132027113GENBIO15222 AVE. OF SCIENCE, San Diego, CA 92128 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0927-2013ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.Multiple incidents of low-reacting assay plates.Class IITerminated

Verification record

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